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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Irrigation, Ocular Surgery
510(k) Number K845039
Device Name OPERAID DISPOS. IRRIGATING KNIFE
Applicant
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Applicant Contact ELI SCHACHER
Correspondent
Jedmed Instrument Co.
1430 Hanley Industrial Ct.
St. Louis,  MO  63144
Correspondent Contact ELI SCHACHER
Regulation Number886.4360
Classification Product Code
KYG  
Date Received12/28/1984
Decision Date 03/05/1985
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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