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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 K881479
Device Name OPERATION ROOM TOWEL
Applicant
Rahn Laboratories
P.O. Box 126
Bland,  VA  24315
Applicant Contact RANDAL J KIRK
Correspondent
Rahn Laboratories
P.O. Box 126
Bland,  VA  24315
Correspondent Contact RANDAL J KIRK
Regulation Number878.4370
Classification Product Code
KKX  
Date Received04/07/1988
Decision Date 04/14/1988
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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