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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Tooth Extractor, Surgical
510(k) Number K840312
Device Name CAT. 8 DENTAL DEVICES
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 Number872.4565
Classification Product Code
EMG  
Date Received01/24/1984
Decision Date 04/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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