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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spud, ophthalmic
510(k) Number K874963
Device Name MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
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 Number886.4350
Classification Product Code
HNA  
Date Received12/02/1987
Decision Date 12/23/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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