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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 K891324
Device Name HERMITEX SPONGE
Applicant
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Applicant Contact JACK E ARNOULD
Correspondent
Hermitage Hospital Products, Inc.
38 Hope St.
Niantic,  CT  06357
Correspondent Contact JACK E ARNOULD
Regulation Number878.4014
Classification Product Code
NAB  
Date Received03/13/1989
Decision Date 04/27/1989
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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