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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Microsurgical
510(k) Number K853179
Device Name VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND
Applicant
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Applicant Contact VAN ARSDALE
Correspondent
Keeler Instruments, Inc.
456 Pkwy.
Broomall,  PA  19008
Correspondent Contact VAN ARSDALE
Regulation Number882.4525
Classification Product Code
GZX  
Date Received07/30/1985
Decision Date 11/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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