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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, pneumatic powered
510(k) Number K960473
Device Name AESCULAP POWER SYSTEM HANDPIECE
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact MARY E HOLDEN
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact MARY E HOLDEN
Regulation Number878.4820
Classification Product Code
GET  
Date Received02/01/1996
Decision Date 03/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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