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 |