The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Contour Necklift Threads.
Device ID | K050247 |
510k Number | K050247 |
Device Name: | CONTOUR NECKLIFT THREADS |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
Contact | Elizabeth Lazaro |
Correspondent | Elizabeth Lazaro SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
Product Code | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-02 |
Decision Date | 2005-03-04 |
Summary: | summary |