The following data is part of a premarket notification filed by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh with the FDA for Disposable Heating Tubing Set #7642hses.
| Device ID | K990662 |
| 510k Number | K990662 |
| Device Name: | DISPOSABLE HEATING TUBING SET #7642HSES |
| Classification | Insufflator, Laparoscopic |
| Applicant | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Contact | S. Grunwald |
| Correspondent | S. Grunwald WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH RUDOLF-DIESEL-RING 20 Sauerlach, DE D-82054 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-09-24 |