The following data is part of a premarket notification filed by Prosurg, Inc. with the FDA for Intrauterine Delivery System - Injector.
| Device ID | K023051 |
| 510k Number | K023051 |
| Device Name: | INTRAUTERINE DELIVERY SYSTEM - INJECTOR |
| Classification | Cannula, Manipulator/injector, Uterine |
| Applicant | PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Ashvin Desai |
| Correspondent | Ashvin Desai PROSURG, INC. 2193 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | LKF |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-13 |
| Decision Date | 2002-12-12 |