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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 K895342
Device Name COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
Applicant
Lacrimedics, Inc.
9008 Newby St.
Rosemead,  CA  91770
Applicant Contact ROBERT HERRICK
Correspondent
Lacrimedics, Inc.
9008 Newby St.
Rosemead,  CA  91770
Correspondent Contact ROBERT HERRICK
Classification Product Code
LZU  
Date Received08/31/1989
Decision Date 11/02/1989
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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