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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 K843491
Device Name CONCEPT FIBER OPTIC CANALICULUS INTUBA
Applicant
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Applicant Contact unknown unknown
Correspondent
Concept, Inc.
12707 U.S. 19 S.
Clearwater,  FL  33546
Correspondent Contact unknown unknown
Regulation Number886.4350
Classification Product Code
HNL  
Date Received09/06/1984
Decision Date 10/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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