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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burr, Corneal, Battery-Powered
510(k) Number K834354
Device Name OPHTEC RUST RING REMOVER
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 Number886.4070
Classification Product Code
HOG  
Date Received12/13/1983
Decision Date 03/19/1984
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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