The following data is part of a premarket notification filed by Coopervision Surgical with the FDA for Leep System 6000 Electrosurgical Unit And Accessor.
| Device ID | K905747 |
| 510k Number | K905747 |
| Device Name: | LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | COOPERVISION SURGICAL 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPERVISION SURGICAL 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937010910 | K905747 | 000 |
| 20888937010798 | K905747 | 000 |
| 20888937010781 | K905747 | 000 |
| 20888937010774 | K905747 | 000 |
| 20888937010767 | K905747 | 000 |
| 20888937010750 | K905747 | 000 |
| 20888937010743 | K905747 | 000 |
| 20888937010736 | K905747 | 000 |
| 20888937010729 | K905747 | 000 |
| 20888937010804 | K905747 | 000 |
| 20888937010811 | K905747 | 000 |
| 20888937010828 | K905747 | 000 |
| 20888937010903 | K905747 | 000 |
| 20888937010897 | K905747 | 000 |
| 20888937010880 | K905747 | 000 |
| 20888937010873 | K905747 | 000 |
| 20888937010866 | K905747 | 000 |
| 20888937010859 | K905747 | 000 |
| 20888937010842 | K905747 | 000 |
| 20888937010835 | K905747 | 000 |
| 20888937010712 | K905747 | 000 |