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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photokeratoscope
510(k) Number K830290
Device Name DORC CONTACT/PHOTO DERATOSCOPE
Applicant
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
JEDMED INSTRUMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1350
Classification Product Code
HJA  
Date Received01/27/1983
Decision Date 03/09/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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