The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Strobex Ultron Electrosurge-dental Unit.
| Device ID | K850666 |
| 510k Number | K850666 |
| Device Name: | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | IPCO CORP. 1025 WESTCHESTER AVE. White Plains, NY 10604 |
| Contact | Leonard L Wolfson |
| Correspondent | Leonard L Wolfson IPCO CORP. 1025 WESTCHESTER AVE. White Plains, NY 10604 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-20 |
| Decision Date | 1985-05-29 |