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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K871263
Device Name MULTIPLE PHARMA-PLAST TRACHEAL TUBE
Applicant
Pharma-Plast USA, Inc.
1801 Mcgill College Ave.
Suite 1470, Montreal
Canada H3a 2n4,  CA
Applicant Contact DOUGLAS M BENNETT
Correspondent
Pharma-Plast USA, Inc.
1801 Mcgill College Ave.
Suite 1470, Montreal
Canada H3a 2n4,  CA
Correspondent Contact DOUGLAS M BENNETT
Regulation Number868.5730
Classification Product Code
BTR  
Date Received03/31/1987
Decision Date 06/15/1987
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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