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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K828583
Device Name LASERMED OCULASE ARGON LASER
Applicant
Lasermed Corp.
151 Kalmus Dr. Bldg. H-3
Costa Mesa,  CA  92626
Correspondent
Lasermed Corp.
151 Kalmus Dr. Bldg. H-3
Costa Mesa,  CA  92626
Date Received11/23/1982
Decision Date 01/14/1983
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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