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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 K940535
Device Name AUTO LUBE SYSTEM
Applicant
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Applicant Contact WILLIAM E ANSPACH
Correspondent
THE ANSPACH EFFORT, INC.
4500 RIVERSIDE DR.
PALM BEACH GARDENS,  FL  33410
Correspondent Contact WILLIAM E ANSPACH
Regulation Number878.4820
Classification Product Code
GEY  
Date Received02/07/1994
Decision Date 03/21/1994
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
Recalls CDRH Recalls
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