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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gag, Mouth
510(k) Number K834540
Device Name OP-CON SURGICAL INSTRUMENT #9
Applicant
IMM ENTERPRISES LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMM ENTERPRISES LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4420
Classification Product Code
KBN  
Date Received12/01/1983
Decision Date 03/06/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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