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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837030
Device Name MODEL ML-4000 OPHTHALMIC LASER WITH FIBER OPTIC DELIVERY SYSTEM
Applicant
Meditec, Inc.
9485 E. Orchard Dr.
Englewood,  CO  80111
Correspondent
Meditec, Inc.
9485 E. Orchard Dr.
Englewood,  CO  80111
Date Received12/20/1982
Decision Date 01/24/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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