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: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
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