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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Lachrymal
510(k) Number K862070
Device Name INTER-SHARP
Applicant
Intermedics Intraocular, Inc.
2650 E. Foothill Blvd.
P.O. Box 70670
Passadena,  CA  91107
Applicant Contact ENID ROKAW
Correspondent
Intermedics Intraocular, Inc.
2650 E. Foothill Blvd.
P.O. Box 70670
Passadena,  CA  91107
Correspondent Contact ENID ROKAW
Regulation Number886.4350
Classification Product Code
HNW  
Date Received05/30/1986
Decision Date 06/17/1986
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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