The following data is part of a premarket notification filed by Mpathy Medical Devices, Ltd. with the FDA for Minitape Urethral Sling.
Device ID | K073646 |
510k Number | K073646 |
Device Name: | MINITAPE URETHRAL SLING |
Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling |
Applicant | MPATHY MEDICAL DEVICES, LTD. 24 BARBERRY LANE Madison, CT 06443 |
Contact | Louis J Mazzarese |
Correspondent | Louis J Mazzarese MPATHY MEDICAL DEVICES, LTD. 24 BARBERRY LANE Madison, CT 06443 |
Product Code | PAH |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-26 |
Decision Date | 2008-02-25 |
Summary: | summary |