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 |