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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K925905
Device Name KIT, SURGICAL INSTRUMENT, DISPOSABLE
Applicant
Kay Medical Concepts
3280-E Peachtree Corners Circl
Norcross,  GA  30092
Applicant Contact KEVIN COUGHLIN
Correspondent
Kay Medical Concepts
3280-E Peachtree Corners Circl
Norcross,  GA  30092
Correspondent Contact KEVIN COUGHLIN
Regulation Number878.4800
Classification Product Code
KDD  
Date Received11/18/1992
Decision Date 06/16/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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