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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Carrier, Fiberoptic Light
510(k) Number K934911
Device Name SAPHIRE PLUS SURGICAL MIRROR
Applicant
San Diego Swiss Machining, Inc.
11222 Walaby Ct.
San Diego,  CA  92128
Applicant Contact ALAN DONALD
Correspondent
San Diego Swiss Machining, Inc.
11222 Walaby Ct.
San Diego,  CA  92128
Correspondent Contact ALAN DONALD
Regulation Number874.4350
Classification Product Code
EQH  
Date Received10/14/1993
Decision Date 06/21/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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