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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 K922843
Device Name DYNAREX SUCTION CATHETERS & KITS
Applicant
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Applicant Contact RANDELL GREEN
Correspondent
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Correspondent Contact RANDELL GREEN
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/12/1992
Decision Date 01/11/1993
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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