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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853199
Device Name INTEGRITY EYE DROP GUIDE(MODIFICATION)
Applicant
Integrity Optics, Inc.
15914 Overview Rd.
Poway,  CA  92014
Applicant Contact ARTHUR C JERMYN
Correspondent
Integrity Optics, Inc.
15914 Overview Rd.
Poway,  CA  92014
Correspondent Contact ARTHUR C JERMYN
Date Received07/31/1985
Decision Date 08/20/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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