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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 K970530
Device Name ANSPACH LUBRICATING SYSTEM II
Applicant
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Applicant Contact WILLIAM E ANSPACH III, MD
Correspondent
The Anspach Effort, Inc.
4500 Riverside Dr.
Palm Beach Gardens,  FL  33410
Correspondent Contact WILLIAM E ANSPACH III, MD
Regulation Number878.4820
Classification Product Code
GEY  
Date Received02/12/1997
Decision Date 05/05/1997
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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