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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sponge, ophthalmic
510(k) Number K002279
Device Name ML EYE SPEAR, MODEL ML 27 ES
Applicant
MED-LOGICS, INC.
30001 GOLDEN LANTERN #334
LAGUNA NIGUEL,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
MED-LOGICS, INC.
30001 GOLDEN LANTERN #334
LAGUNA NIGUEL,  CA  92677
Correspondent Contact GARY MOCNIK
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received07/26/2000
Decision Date 08/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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