FDA releases July 2016 510(k) clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD July 2016 TOTAL 510(k)s THIS PERIOD 236 TOTAL WITH SUMMARIES 220 TOTAL WITH STATEMENTS 16 DEVICE: Dakin's Skin and Wound Cleanser CENTURY PHARMACEUTICALS, INC. 510(k) NO: K150208(Traditional) ATTN: Stephen Deardorff PHONE NO : 1 317 8494210 10377 HAGUE RD. SE DECISION MADE: 21-JUL-16 INDIANAPOLIS IN 46256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Sheath Introducer BIOTEQUE CORP. 510(k) NO: K150932(Traditional) ATTN: Simon Lin PHONE NO : 886 2 25710269 5 F-6, NO. 23, SEC. 1 CHANG-AN E. SE DECISION MADE: 22-JUL-16 TAIPEI TW 104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: The Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Compan510(k) NO: K151424(Traditional) ATTN: Scott Keiser PHONE NO : 561 4404460 801 US Highway 1, Suite B SE DECISION MADE: 27-JUL-16 North Palm Beach FL 33408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ET III Bio-SA Fixture System HiOSSEN Inc. 510(k) NO: K151626(Traditional) ATTN: David Kim PHONE NO : 267 759 7031 85 Ben Fairless Dr. SE DECISION MADE: 21-JUL-16 Fairless Hills PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMT Platinum Depthalon Depth Electrode PMT CORPO...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news