The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Novasilk Mesh.
Device ID | K053414 |
510k Number | K053414 |
Device Name: | MENTOR NOVASILK MESH |
Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
Applicant | MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
Contact | Donna A Crawford |
Correspondent | Donna A Crawford MENTOR CORP. 201 MENTOR DRIVE Santa Barbara, CA 93111 |
Product Code | OTP |
Subsequent Product Code | OTO |
Subsequent Product Code | PAI |
Subsequent Product Code | PAJ |
CFR Regulation Number | 884.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-07 |
Decision Date | 2005-12-27 |
Summary: | summary |