The following data is part of a premarket notification filed by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh with the FDA for Flow-therme, Wisap #7642.
| Device ID | K952508 |
| 510k Number | K952508 |
| Device Name: | FLOW-THERME, WISAP #7642 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Contact | Horst Semn |
| Correspondent | Horst Semn WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-31 |
| Decision Date | 1995-08-25 |