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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K990861
Device Name WOUND DRESSING/ABD PAD, MODEL #10810
Applicant
Hospital Specialty Co.
7501 Carnegie Ave.
Cleveland,  OH  44103
Applicant Contact JOHN QUIGLEY
Correspondent
Hospital Specialty Co.
7501 Carnegie Ave.
Cleveland,  OH  44103
Correspondent Contact JOHN QUIGLEY
Regulation Number878.4020
Classification Product Code
NAD  
Date Received03/16/1999
Decision Date 04/12/1999
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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