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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 (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No