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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 K850389
Device Name MULTIPLE OUTLET MANIFOLD
Applicant
THE ANSPACH EFFORT, INC.
1349 S. KILLIAN DR.
LAKE PARK,  FL  33403
Applicant Contact ANSPACH
Correspondent
THE ANSPACH EFFORT, INC.
1349 S. KILLIAN DR.
LAKE PARK,  FL  33403
Correspondent Contact ANSPACH
Regulation Number878.4820
Classification Product Code
GEY  
Date Received02/01/1985
Decision Date 03/18/1985
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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