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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K895395
Device Name V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
Applicant
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Applicant Contact MATHEW NOWLAND
Correspondent
Baxter Healthcare Corp
7280 N. Caldwell
Niles,  IL  60648
Correspondent Contact MATHEW NOWLAND
Regulation Number882.4800
Classification Product Code
GZT  
Date Received09/01/1989
Decision Date 10/19/1989
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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