The following data is part of a premarket notification filed by Quill Medical, Inc. with the FDA for Quill Synthetic Absorbable Barbed Suture.
Device ID | K051609 |
510k Number | K051609 |
Device Name: | QUILL SYNTHETIC ABSORBABLE BARBED SUTURE |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | QUILL MEDICAL, INC. 2505 MERIDIAN PKWY. SUITE 150 Research Triangle Park, NC 27713 |
Contact | Lois V Smart |
Correspondent | Lois V Smart QUILL MEDICAL, INC. 2505 MERIDIAN PKWY. SUITE 150 Research Triangle Park, NC 27713 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-17 |
Decision Date | 2005-08-04 |
Summary: | summary |