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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K971988
Device Name ALLEN, ULTRA AND SMART SOCKETS
Applicant
Allen Medical Systems, Inc.
15627 Neo Pkwy.
Cleveland,  OH  44128
Applicant Contact SUZANNE KAY RATZLOFF
Correspondent
Allen Medical Systems, Inc.
15627 Neo Pkwy.
Cleveland,  OH  44128
Correspondent Contact SUZANNE KAY RATZLOFF
Regulation Number878.4960
Classification Product Code
FQO  
Subsequent Product Codes
FWW   GDC  
Date Received05/29/1997
Decision Date 07/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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