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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, X-Ray Detectable
510(k) Number K822623
Device Name LAPAROTOMY SPONGE
Applicant
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Correspondent
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/30/1982
Decision Date 10/13/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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