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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K852280
Device Name DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY)
Applicant
Outpatient Products Co.
Postal Box 18354
Asheville,  NC  28814
Applicant Contact LYMAN R MARSHALL
Correspondent
Outpatient Products Co.
Postal Box 18354
Asheville,  NC  28814
Correspondent Contact LYMAN R MARSHALL
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/29/1985
Decision Date 07/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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