The following data is part of a premarket notification filed by Surgical Specialties Corp. Dba Angiotech with the FDA for Quill Polypropylene Knotless Tissue-closure Device, Variable Loop Design.
| Device ID | K130078 |
| 510k Number | K130078 |
| Device Name: | QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell SURGICAL SPECIALTIES CORP. DBA ANGIOTECH 100 DENNIS DR. Reading, PA 19606 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-14 |
| Decision Date | 2013-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782020550 | K130078 | 000 |
| 20705031228129 | K130078 | 000 |