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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Battery-Powered
510(k) Number K944402
Device Name FOCOMETER
Applicant
Lacrimedics, Inc.
190 N. Arrowhead Ave.,
Suite B
Rialto,  CA  92376
Applicant Contact ROBERT S HERRICK II
Correspondent
Lacrimedics, Inc.
190 N. Arrowhead Ave.,
Suite B
Rialto,  CA  92376
Correspondent Contact ROBERT S HERRICK II
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received09/12/1994
Decision Date 11/22/1994
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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