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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 K912767
Device Name FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC
Applicant
Microaire Advanced Surgical Products
24907 Ave. Tibbetts
Unit A
Valencia,  CA  91355
Applicant Contact SIDDHARTH DESAI
Correspondent
Microaire Advanced Surgical Products
24907 Ave. Tibbetts
Unit A
Valencia,  CA  91355
Correspondent Contact SIDDHARTH DESAI
Regulation Number874.4350
Classification Product Code
EQH  
Date Received06/24/1991
Decision Date 08/13/1991
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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