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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sponge, Ophthalmic
510(k) Number K910707
Device Name OPERAID SURGICAL DRAIN W/ CORNEAL SHIELDS
Applicant
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Applicant Contact CRAIG RAPP
Correspondent
JEDMED INSTRUMENT CO.
6096 LEMAY FERRY RD.
ST.LOUIS,  MO  63129 -2217
Correspondent Contact CRAIG RAPP
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received02/20/1991
Decision Date 04/10/1991
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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