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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K980357
Device Name KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
Applicant
Konan, Inc.
377 Rte. 17s
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE H MYERS
Correspondent
Konan, Inc.
377 Rte. 17s
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE H MYERS
Regulation Number886.1120
Classification Product Code
HKI  
Date Received01/29/1998
Decision Date 04/24/1998
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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