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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 K912522
Device Name OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER
Applicant
Summit Technology, Inc.
21 Hickory Dr.
Waltham,  MA  02154
Applicant Contact KIMBERLEY DONEY
Correspondent
Summit Technology, Inc.
21 Hickory Dr.
Waltham,  MA  02154
Correspondent Contact KIMBERLEY DONEY
Regulation Number874.4350
Classification Product Code
EQH  
Date Received05/22/1991
Decision Date 07/25/1991
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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