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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Tube Introduction
510(k) Number K834169
Device Name OP-CON SURGICAL INSTRUMENT #9
Applicant
IMM ENTERPRISES LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
IMM ENTERPRISES LTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5780
Classification Product Code
BWB  
Date Received11/21/1983
Decision Date 01/17/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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