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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 K113839
Device Name RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
Applicant
PARKELL, INC.
300 EXECUTIVE DR.
EDGEWOOD,  NY  11717
Applicant Contact DANIEL R SCHECHTER
Correspondent
PARKELL, INC.
300 EXECUTIVE DR.
EDGEWOOD,  NY  11717
Correspondent Contact DANIEL R SCHECHTER
Classification Product Code
MVL  
Date Received12/28/2011
Decision Date 04/12/2012
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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