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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K042885
Device Name OCT-OPTHALMOSCOPE
Applicant
Ophthalmic Technologies, Inc.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Ophthalmic Technologies, Inc.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number886.1570
Classification Product Code
HLI  
Date Received10/19/2004
Decision Date 01/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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