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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name splint, endodontic stabilizing
510(k) Number K811209
Device Name JACOB WIRZ TRANSFIXATION PIN
Applicant
COLMED, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
COLMED, LTD.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.3890
Classification Product Code
ELS  
Date Received05/01/1981
Decision Date 06/16/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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