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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K953226
Device Name PULM O2 SUCTION CATHETER TRAYS
Applicant
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Applicant Contact GARY GARBIN
Correspondent
Premium Plastics, Inc.
465 W. Cermak Rd.
Chicago,  IL  60616
Correspondent Contact GARY GARBIN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received07/06/1995
Decision Date 08/08/1995
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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