The following data is part of a premarket notification filed by Womancare Global with the FDA for Rigid Cannulae Curved (rc6-rc12), Rigid Cannulae Straight (rs6-rs12).
Device ID | K093508 |
510k Number | K093508 |
Device Name: | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) |
Classification | Cannula, Suction, Uterine |
Applicant | WOMANCARE GLOBAL 300 MARKET ST. SUITE 134 Chapel Hill, NC 27516 |
Contact | Susanne Parks |
Correspondent | Susanne Parks WOMANCARE GLOBAL 300 MARKET ST. SUITE 134 Chapel Hill, NC 27516 |
Product Code | HGH |
CFR Regulation Number | 884.5070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-12 |
Decision Date | 2010-03-04 |
Summary: | summary |