RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE

Cord, Retraction

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Retract Gingival Retraction/hemostatic Paste.

Pre-market Notification Details

Device IDK113839
510k NumberK113839
Device Name:RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
ClassificationCord, Retraction
Applicant PARKELL, INC. 300 EXECUTIVE DR. Edgewood,  NY  11717
ContactDaniel R Schechter
CorrespondentDaniel R Schechter
PARKELL, INC. 300 EXECUTIVE DR. Edgewood,  NY  11717
Product CodeMVL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-28
Decision Date2012-04-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.