The following data is part of a premarket notification filed by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh with the FDA for S*e*m*m* Set For Moto Drive Wisap #7689 Ssm (modification).
| Device ID | K960640 |
| 510k Number | K960640 |
| Device Name: | S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH 8305 MELROSE DR. Lenexa, KS 66214 |
| Contact | Jay Sullivan |
| Correspondent | Jay Sullivan WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH 8305 MELROSE DR. Lenexa, KS 66214 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-12 |
| Decision Date | 1997-02-14 |