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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K953072
Device Name MEROCEL VAGINAL PACK
Applicant
Merocel Corp.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact DAVID TIMLIN
Correspondent
Merocel Corp.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact DAVID TIMLIN
Classification Product Code
EFQ  
Subsequent Product Code
HDM  
Date Received06/30/1995
Decision Date 09/12/1995
Decision Substantially Equivalent (SESE)
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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