FDA releases April 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD April 2016 TOTAL 510(k)s THIS PERIOD 239 TOTAL WITH SUMMARIES 224 TOTAL WITH STATEMENTS 15 DEVICE: Applanation Tonometer SHANGHAI MEDIWORKS PRECISION INSTR510(k) NO: K142263(Traditional) ATTN: Weida Zhan PHONE NO : 8621 542 60421 Zone A, 2nd Floor, No. 69, Lane 19SE DECISION MADE: 15-APR-16 SHANGHAI CN 200237 510(k) STATEMENT DEVICE: Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test Sugentech, Inc. 510(k) NO: K142754(Traditional) ATTN: Mijin Sohn PHONE NO : 82 42 3645001 Daejeon Bioventure Town, 1662, YusSE DECISION MADE: 07-APR-16 Daejeon KR 305-811 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Nitrile Patient Examination gloves, Powderfree, Blue color PRIMUS GLOVES PVT LIMITED 510(k) NO: K143477(Traditional) ATTN: JOSE PAUL M PHONE NO : 91 484 2413063 PLOT No: 14-A, COCHIN SPECIAL ECONSE DECISION MADE: 14-APR-16 COCHIN IN 682037 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUE METRIX GO Self Monitoring Blood Glucose System Trividia Health, Inc. 510(k) NO: K143548(Traditional) ATTN: Beth Foster PHONE NO : 1 954 6779201 3044 2400 NW 55TH COURT SE DECISION MADE: 01-APR-16 Fort Lauderdale FL 33309 510(k) STATEMENT DEVICE: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer GLOBUS MEDICAL INC. 510(k) NO:...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news