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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 K841721
Device Name OPERAID SURGICAL DRAIN
Applicant
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Applicant Contact ELI SCHACHET
Correspondent
JEDMED INSTRUMENT CO.
1430 HANLEY INDUSTRIAL CT.
ST. LOUIS,  MO  63144
Correspondent Contact ELI SCHACHET
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received04/25/1984
Decision Date 11/21/1984
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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