The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Suspend Sling.
Device ID | K980483 |
510k Number | K980483 |
Device Name: | MENTOR SUSPEND SLING |
Classification | Mesh, Surgical, Polymeric |
Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
Contact | Donna A Crawford |
Correspondent | Donna A Crawford MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-09 |
Decision Date | 1998-04-30 |
Summary: | summary |