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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. SOUTH
COTTAGE GROVE,  MN  55016
Applicant Contact H BARROWS
Correspondent
ORTHOFAB, INC.
7464 IRVIN AVE. SOUTH
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
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