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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 K911932
Device Name J105 JAMES SURGICAL SYSTEM I/A PACK
Applicant
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Applicant Contact JACK W HOWARD
Correspondent
O.R. Specialties, Inc.
4749 Appletree Ln.
Tuscaloosa,  AL  35405
Correspondent Contact JACK W HOWARD
Regulation Number882.4525
Classification Product Code
GZX  
Date Received04/30/1991
Decision Date 08/26/1991
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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