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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheostomy (W/Wo Connector)
510(k) Number K924195
Device Name TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
Applicant
American Healthcare Corp.
One American Healthcare Plz.
3611 Kennedy Rd.
South Plainfield,  NJ  07080
Applicant Contact RALPH S JARRETT
Correspondent
American Healthcare Corp.
One American Healthcare Plz.
3611 Kennedy Rd.
South Plainfield,  NJ  07080
Correspondent Contact RALPH S JARRETT
Regulation Number868.5800
Classification Product Code
BTO  
Date Received08/20/1992
Decision Date 01/06/1993
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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