The following data is part of a premarket notification filed by Surgical Specialties Corporation with the FDA for Quill Monoderm Knotless Tissue-closure Device, Variable Loop Design.
Device ID | K141778 |
510k Number | K141778 |
Device Name: | QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | SURGICAL SPECIALTIES CORPORATION 100 DENNIS DRIVE Reading, PA 19606 |
Contact | Kirsten Stowell Franco |
Correspondent | Kirsten Stowell Franco SURGICAL SPECIALTIES CORPORATION 100 DENNIS DRIVE Reading, PA 19606 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-02 |
Decision Date | 2014-07-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10848782020536 | K141778 | 000 |
10848782020529 | K141778 | 000 |
10848782040060 | K141778 | 000 |
10848782004772 | K141778 | 000 |