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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 K852234
Device Name MDS 83 OPHTHALMIC DYE LASER SYSTEM
Applicant
Meditec, Inc.
616 E. St.
Clearwater,  FL  33516
Applicant Contact TONEY G HOWARD
Correspondent
Meditec, Inc.
616 E. St.
Clearwater,  FL  33516
Correspondent Contact TONEY G HOWARD
Regulation Number886.4390
Classification Product Code
HQF  
Date Received05/22/1985
Decision Date 08/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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