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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K860928
Device Name EYEMETER
Applicant
Indivisual Corporation, Inc.
Counsel For Indivisual Corp.
10900 Wilshire Blvd.
Los Angeles,  CA  90024
Applicant Contact ROBERT B HUBBEL
Correspondent
Indivisual Corporation, Inc.
Counsel For Indivisual Corp.
10900 Wilshire Blvd.
Los Angeles,  CA  90024
Correspondent Contact ROBERT B HUBBEL
Date Received03/11/1986
Decision Date 04/04/1986
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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