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 Monoderm.
Device ID | K072028 |
510k Number | K072028 |
Device Name: | QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
Contact | Lois Smart |
Correspondent | Lois Smart SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-24 |
Decision Date | 2007-08-03 |
Summary: | summary |