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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 K761190
Device Name TRACHEOSTOMY CARE KIT
Applicant
Superior Plastic Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Superior Plastic Products Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5800
Classification Product Code
BTO  
Date Received12/06/1976
Decision Date 12/16/1976
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
Recalls CDRH Recalls
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