The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Quill Self-retaining System (srs) Comprised Of Pdo (polydioxanone.
Device ID | K080680 |
510k Number | K080680 |
Device Name: | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | SURGICAL SPECIALTIES CORP. 13921 PARK CENTER RD. SUITE 200 Herndon, VA 20171 |
Contact | Trudy D Estridge |
Correspondent | Trudy D Estridge SURGICAL SPECIALTIES CORP. 13921 PARK CENTER RD. SUITE 200 Herndon, VA 20171 |
Product Code | NEW |
CFR Regulation Number | 878.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-10 |
Decision Date | 2008-03-21 |
Summary: | summary |