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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cord, retraction
510(k) Number K041023
Device Name STAY-PUT IMPREGNATED
Applicant
COLTENE/WHALEDENT GMBH & CO. KG
CARE OF HENRY J. VOGELSTEIN
1349 LEXINGTON AVE.
NEW YORK,  NY  10128
Applicant Contact HENRY J VOGELSTEIN
Correspondent
COLTENE/WHALEDENT GMBH & CO. KG
CARE OF HENRY J. VOGELSTEIN
1349 LEXINGTON AVE.
NEW YORK,  NY  10128
Correspondent Contact HENRY J VOGELSTEIN
Classification Product Code
MVL  
Date Received04/20/2004
Decision Date 06/15/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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