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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name motor, surgical instrument, ac-powered
510(k) Number K913262
Device Name AESCULAP SURGICAL ACCESSORIES
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact VICTORIA MACKINNON
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact VICTORIA MACKINNON
Regulation Number878.4820
Classification Product Code
GEY  
Date Received07/23/1991
Decision Date 12/30/1991
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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