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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 K852661
Device Name APOLLO STERILE BLADES
Applicant
Orthofab, Inc.
7464 Irvin Ave. S.
Cottage Grove,  MN  55016
Applicant Contact H BARROWS
Correspondent
Orthofab, Inc.
7464 Irvin Ave. S.
Cottage Grove,  MN  55016
Correspondent Contact H BARROWS
Regulation Number878.4800
Classification Product Code
GES  
Date Received06/24/1985
Decision Date 07/11/1985
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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