The following data is part of a premarket notification filed by R-group Intl. with the FDA for Disposable And Reusable Ball And Loop Electrodes.
| Device ID | K993777 |
| 510k Number | K993777 |
| Device Name: | DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | R-GROUP INTL. 2321 N.W. 66TH CT., SUITE W-4 Gainesville, FL 32653 |
| Contact | Kerry A Kahn |
| Correspondent | Kerry A Kahn R-GROUP INTL. 2321 N.W. 66TH CT., SUITE W-4 Gainesville, FL 32653 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-08 |
| Decision Date | 2000-05-25 |