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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tracheotome
510(k) Number K822618
Device Name EMERGENCY TRACHEOSTOMY INSTRUMENT SET
Applicant
Kelleher Corp.
1301 School St.
Richmond,  VA  23220
Applicant Contact FRANCIS J KELLEHER
Correspondent
Kelleher Corp.
1301 School St.
Richmond,  VA  23220
Correspondent Contact FRANCIS J KELLEHER
Regulation Number874.4420
Classification Product Code
LJW  
Date Received09/02/1982
Decision Date 01/28/1983
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
Predetermined Change
Control Plan Authorized		 No
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