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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name saw, manual and accessories
510(k) Number K874961
Device Name BONE CUTTING INSTRUMENTS & ACCESSORIES
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 Number878.4800
Classification Product Code
GDR  
Date Received12/02/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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