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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 K082116
Device Name HEMOSTASYL PASTE
Applicant
SATELEC
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
SATELEC
124 GAITHER DRIVE
SUITE 140
MT. LAUREL,  NJ  08054
Correspondent Contact RICK ROSATI
Classification Product Code
MVL  
Date Received07/28/2008
Decision Date 12/17/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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