The following data is part of a premarket notification filed by Palm Medical Usa, Inc. with the FDA for Loop Electrode, Ball Electrode.
| Device ID | K993527 |
| 510k Number | K993527 |
| Device Name: | LOOP ELECTRODE, BALL ELECTRODE |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | PALM MEDICAL USA, INC. 6322 N.W. 18TH DR., SUITE 170 Gainesville, FL 32653 |
| Contact | Mark J Kahn |
| Correspondent | Mark J Kahn PALM MEDICAL USA, INC. 6322 N.W. 18TH DR., SUITE 170 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 | 1999-10-18 |
| Decision Date | 2000-07-06 |