The following data is part of a premarket notification filed by Novabone Products, Llc with the FDA for Dental Collagen Wound Dressing (nova Tape And Novaplug).
| Device ID | K142712 |
| 510k Number | K142712 |
| Device Name: | Dental Collagen Wound Dressing (Nova Tape And NovaPlug) |
| Classification | Dressing, Wound, Collagen |
| Applicant | NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813909011479 | K142712 | 000 |
| 00813909011462 | K142712 | 000 |
| 00813909010588 | K142712 | 000 |
| 00813909010564 | K142712 | 000 |
| 00813909010267 | K142712 | 000 |
| 00813909010250 | K142712 | 000 |