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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 K874956
Device Name SELF-RETAINING RETRACTOR FOR NEUROSURGERY
Applicant
Solway, Inc.
Post Office Box 7647
Hollywood,  FL  33081
Applicant Contact MARTIN MUNZER
Correspondent
Solway, Inc.
Post Office Box 7647
Hollywood,  FL  33081
Correspondent Contact MARTIN MUNZER
Regulation Number882.4800
Classification Product Code
GZT  
Date Received12/02/1987
Decision Date 01/28/1988
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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