The following data is part of a premarket notification filed by Quill Medical, Inc. with the FDA for Quill Nonabsorbable Polypropylene Barbed Suture.
Device ID | K052373 |
510k Number | K052373 |
Device Name: | QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | QUILL MEDICAL, INC. 2505 MERIDIAN PARKWAY SUITE 150 Research Triangle Park, NC 27713 |
Contact | Lois V Smart |
Correspondent | Lois V Smart QUILL MEDICAL, INC. 2505 MERIDIAN PARKWAY SUITE 150 Research Triangle Park, NC 27713 |
Product Code | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-08-30 |
Decision Date | 2005-09-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10848782016973 | K052373 | 000 |
10848782016959 | K052373 | 000 |
10848782016935 | K052373 | 000 |
10848782016911 | K052373 | 000 |
10848782016898 | K052373 | 000 |
10848782016874 | K052373 | 000 |
20705031208206 | K052373 | 000 |
20705031208190 | K052373 | 000 |