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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name probe, lachrymal
510(k) Number K840861
Device Name TSE-ANDERSON MODIFIED LACRIMAL GROOV
Applicant
HANSEN OPHTHALMIC DEVELOPMENT LAB
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HANSEN OPHTHALMIC DEVELOPMENT LAB
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4350
Classification Product Code
HNL  
Date Received02/24/1984
Decision Date 05/09/1984
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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