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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name blade, scalpel
510(k) Number K834195
Device Name JAKOBI SURG. INSTRUMENTS #11 11/13/14
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 Number878.4800
Classification Product Code
GES  
Date Received11/21/1983
Decision Date 01/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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