The following data is part of a premarket notification filed by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh with the FDA for Co2-op-pneu Computer, Wisap #7050c, #7050cf, #7050cmf.
| Device ID | K992481 |
| 510k Number | K992481 |
| Device Name: | CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Contact | H. Semm |
| Correspondent | H. 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 | 1999-07-26 |
| Decision Date | 2000-03-17 |