The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for G-sperm, Model 10032.
| Device ID | K022247 |
| 510k Number | K022247 |
| Device Name: | G-SPERM, MODEL 10032 |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB 1800 MASSACHUSETTS AVENUE NW Washington, DC 20036 -1800 |
| Contact | Gary L Yingling |
| Correspondent | Gary L Yingling VITROLIFE SWEDEN AB 1800 MASSACHUSETTS AVENUE NW Washington, DC 20036 -1800 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-12 |
| Decision Date | 2002-09-06 |
| Summary: | summary |