The following data is part of a premarket notification filed by Dmg Usa, Inc. with the FDA for Retraction Paste.
| Device ID | K130580 |
| 510k Number | K130580 |
| Device Name: | RETRACTION PASTE |
| Classification | Cord, Retraction |
| Applicant | DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau, Rac |
| Correspondent | Pamela Papineau, Rac DMG USA, INC. 5 WHITCOMB AVE. Ayer, MA 01432 |
| 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 | 2013-03-05 |
| Decision Date | 2014-02-25 |
| Summary: | summary |