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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Battery-Powered
510(k) Number K864639
Device Name REUSABLE SURGICAL KERATOSCOPE
Applicant
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Applicant Contact CRAIG RAPP
Correspondent
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Correspondent Contact CRAIG RAPP
Regulation Number886.1350
Classification Product Code
HLR  
Date Received11/26/1986
Decision Date 12/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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