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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,Nonresorbable For External Use
510(k) Number K931610
Device Name OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
Applicant
Omni Mfg., Inc.
P.O. Box 1808
Eaton Park,  FL  33840
Applicant Contact MARK J LEMKO
Correspondent
Omni Mfg., Inc.
P.O. Box 1808
Eaton Park,  FL  33840
Correspondent Contact MARK J LEMKO
Regulation Number878.4014
Classification Product Code
NAB  
Date Received04/01/1993
Decision Date 06/24/1993
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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