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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps
510(k) Number K834542
Device Name H.R. JAKOBI SURG. INSTRU. SECT. 48
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 Number878.4800
Classification Product Code
HTD  
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
Predetermined Change
Control Plan Authorized		 No
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