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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 K955165
Device Name SYNTHETIC SPONGE
Applicant
Igenics, Inc.
One Beacon St.
Boston,  MA  02108
Applicant Contact G. THACHER STORM
Correspondent
Igenics, Inc.
One Beacon St.
Boston,  MA  02108
Correspondent Contact G. THACHER STORM
Classification Product Code
EFQ  
Date Received11/13/1995
Decision Date 02/05/1996
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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