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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Scrub, Operating-Room
510(k) Number K791736
Device Name MEROCEL INSTRUMENT WIPE
Applicant
Xomed, Inc.
8641 Baypine Rd.
Jacksonville,  FL  32216
Applicant Contact Don Bruce
Correspondent
Xomed, Inc.
8641 Baypine Rd.
Jacksonville,  FL  32216
Correspondent Contact Don Bruce
Regulation Number878.4800
Classification Product Code
GEC  
Date Received08/31/1979
Decision Date 09/19/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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