The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Neotract Anchor System.
Device ID | K073651 |
510k Number | K073651 |
Device Name: | NEOTRACT ANCHOR SYSTEM |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
Contact | Suzan Moser |
Correspondent | Suzan Moser NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-26 |
Decision Date | 2008-02-01 |
Summary: | summary |