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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K081946
Device Name SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR
Applicant
QUANTEL MEDICAL
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
QUANTEL MEDICAL
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/08/2008
Decision Date 03/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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