The following data is part of a premarket notification filed by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh with the FDA for Power-drive, Wisap Model #7688pd/7688pd1.
| Device ID | K982515 |
| 510k Number | K982515 |
| Device Name: | POWER-DRIVE, WISAP MODEL #7688PD/7688PD1 |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Contact | Horst Semm |
| Correspondent | Horst Semm 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 | 1998-07-20 |
| Decision Date | 1999-01-19 |