The following data is part of a premarket notification filed by Bruce Mclucas with the FDA for Cervical Loop Electrode & Rollerball Electrode.
| Device ID | K923628 |
| 510k Number | K923628 |
| Device Name: | CERVICAL LOOP ELECTRODE & ROLLERBALL ELECTRODE |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | BRUCE MCLUCAS 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Peter O Sadir |
| Correspondent | Peter O Sadir BRUCE MCLUCAS 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1994-02-22 |