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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K121405
Device Name PANOPTIC
Original Applicant
4341 state st. rd.
po box 220
skaneateles falls,  NY  13153 -0020
Original Contact kevin crossen
Regulation Number886.1120
Classification Product Code
Date Received05/10/2012
Decision Date 12/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No