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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoilluminator
510(k) Number K971679
Device Name I-SCOPE OPHTHALMIC ENDOSCOPE
Applicant
OPHTHALMIC TECHNOLOGIES, INC.
37 KODIAK CRESCENT
UNIT 16
DOWNSVIEW, ONTARIO,  CA M3J 3E5
Applicant Contact RICHARD WEITZ
Correspondent
OPHTHALMIC TECHNOLOGIES, INC.
37 KODIAK CRESCENT
UNIT 16
DOWNSVIEW, ONTARIO,  CA M3J 3E5
Correspondent Contact RICHARD WEITZ
Regulation Number876.1500
Classification Product Code
MPA  
Date Received05/07/1997
Decision Date 06/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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