The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Tactile Plus Dental Elevators.
| Device ID | K850906 |
| 510k Number | K850906 |
| Device Name: | TACTILE PLUS DENTAL ELEVATORS |
| Classification | Elevator, Surgical, 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 | EMJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-04-12 |