The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Hsa-solution, Model 10034/10064.
| Device ID | K021896 |
| 510k Number | K021896 |
| Device Name: | HSA-SOLUTION, MODEL 10034/10064 |
| 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 | 2002-06-10 |
| Decision Date | 2002-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025910253 | K021896 | 000 |