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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 K923041
Device Name INTESTINAL SPONGES
Applicant
Surgic Aid, Inc.
576 Mammoth Rd. (Rd1)
Londonderry,  NH  03053
Applicant Contact PAUL W O'REILLY
Correspondent
Surgic Aid, Inc.
576 Mammoth Rd. (Rd1)
Londonderry,  NH  03053
Correspondent Contact PAUL W O'REILLY
Classification Product Code
EFQ  
Date Received06/19/1992
Decision Date 08/10/1992
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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