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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 K093721
Device Name COSP2
Applicant
3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Applicant Contact DESI W SOEGIARTO
Correspondent
3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Correspondent Contact DESI W SOEGIARTO
Classification Product Code
MVL  
Date Received12/02/2009
Decision Date 02/19/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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