The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Dento-surge.
| Device ID | K955176 |
| 510k Number | K955176 |
| Device Name: | DENTO-SURGE |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841494102517 | K955176 | 000 |