dilluns, 8 de desembre del 2014

Medtech regulation: FDA releases November 2014 510(k) decisions




The U.S. Food & Drug Administration releases a list of 510(k) clearances granted in November 2014.





FDA logo

TOTAL 510(k)s THIS PERIOD 238

TOTAL WITH SUMMARIES 222

TOTAL WITH STATEMENTS 16


DEVICE: J-SCREW COMPRESSION SCREW

COMPETITIVE ENGINEERING INC. 510(k) NO: K130019(Traditional)

ATTN: DAVID M DAVIS PHONE NO : 520 746-0270 106

3371 E. HEMISPHERE LOOP SE DECISION MADE: 18-NOV-14

TUCSON AZ 85706 510(k) SUMMARY AVAILABLE FROM FDA


DEVICE: UNEXEF-38G ULTRASOUND SYSTEM




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