The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Cook Word Bartholin Gland Catheter (final Trade Name Not Yet Determined).
Device ID | K102141 |
510k Number | K102141 |
Device Name: | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) |
Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
Applicant | COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
Contact | Cindy Foote |
Correspondent | Cindy Foote COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. Spencer, IN 47460 |
Product Code | KNA |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-29 |
Decision Date | 2011-05-06 |
Summary: | summary |