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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Surgical, Non-Powered
510(k) Number K874962
Device Name FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS
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 Number882.4535
Classification Product Code
HAO  
Date Received12/02/1987
Decision Date 02/02/1988
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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