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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Tracheal
510(k) Number K822260
Device Name TRACHEAL DILATORS
Applicant
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KELLEHER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.4420
Classification Product Code
KCG  
Date Received07/29/1982
Decision Date 09/02/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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