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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tracheotomy Care Kit
510(k) Number K844051
Device Name SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
Applicant
Washington-Greene County Branch Pennsylvania Assoc
566 E. Maiden St.
Washington,  PA  15301
Applicant Contact DENNIS R CHARLTON
Correspondent
Washington-Greene County Branch Pennsylvania Assoc
566 E. Maiden St.
Washington,  PA  15301
Correspondent Contact DENNIS R CHARLTON
Regulation Number868.5800
Classification Product Code
NXA  
Date Received10/17/1984
Decision Date 01/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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