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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 K812071
Device Name RK IV SURGICAL BLADES
Applicant
Santa Barbara Medco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Santa Barbara Medco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GES  
Date Received07/21/1981
Decision Date 08/31/1981
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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