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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plug, Punctum
510(k) Number K022043
Device Name SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503
Applicant
MEDENNIUM, INC.
15350 BARRANCA PKWY.
IRVINE,  CA  92618
Applicant Contact JULIAN ABADIA
Correspondent
MEDENNIUM, INC.
15350 BARRANCA PKWY.
IRVINE,  CA  92618
Correspondent Contact JULIAN ABADIA
Classification Product Code
LZU  
Date Received06/24/2002
Decision Date 10/18/2002
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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