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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Surgical
510(k) Number K954263
Device Name XE-LITE
Applicant
Ophthalmic Technologies, Inc.
37 Kodiak Crescent,
Unit 12
Downsview, Ontario,  CA MEJ 3E5
Applicant Contact RISHARD WEITZ
Correspondent
Ophthalmic Technologies, Inc.
37 Kodiak Crescent,
Unit 12
Downsview, Ontario,  CA MEJ 3E5
Correspondent Contact RISHARD WEITZ
Regulation Number878.4580
Classification Product Code
FTD  
Date Received09/12/1995
Decision Date 10/18/1995
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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