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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Scalpel
510(k) Number K900266
Device Name STERILE CARBON STEEL SURGICAL BLADE
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 Number878.4800
Classification Product Code
GES  
Date Received01/18/1990
Decision Date 03/01/1990
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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