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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 K070776
Device Name SUPRA 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 Received03/21/2007
Decision Date 04/24/2007
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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