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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K983348
Device Name DYNAREX TRACHEOSTOMY SPONGE
Applicant
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Applicant Contact JOHN G MOULDEN
Correspondent
Dynarex Corp.
One International Blvd.
Brewster,  NY  10509
Correspondent Contact JOHN G MOULDEN
Classification Product Code
EFQ  
Date Received09/23/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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