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 |