The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Retract Gingival Retraction/hemostatic Paste.
Device ID | K113839 |
510k Number | K113839 |
Device Name: | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE |
Classification | Cord, Retraction |
Applicant | PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
Contact | Daniel R Schechter |
Correspondent | Daniel R Schechter PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
Product Code | MVL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-28 |
Decision Date | 2012-04-12 |
Summary: | summary |