The following data is part of a premarket notification filed by Sorbx, Llc with the FDA for Absorbatack And Applicator.
| Device ID | K071061 |
| 510k Number | K071061 |
| Device Name: | ABSORBATACK AND APPLICATOR |
| Classification | Staple, Implantable |
| Applicant | SORBX, LLC PO BOX 3614 Ponte Vedra Beach, FL 32004 |
| Contact | Mary Lee Willets |
| Correspondent | Mary Lee Willets SORBX, LLC PO BOX 3614 Ponte Vedra Beach, FL 32004 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-16 |
| Decision Date | 2007-05-16 |