The following data is part of a premarket notification filed by Meditron Devices, Inc. with the FDA for Universal Generator Irrigator Model Ugi-3000.
| Device ID | K884836 |
| 510k Number | K884836 |
| Device Name: | UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-3000 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDITRON DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Contact | Samuel Dickstein |
| Correspondent | Samuel Dickstein MEDITRON DEVICES, INC. 83 HOBART ST. Hackensack, NJ 07601 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1988-12-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333241408 | K884836 | 000 |
| 04961333241187 | K884836 | 000 |
| 04961333241217 | K884836 | 000 |
| 04961333241224 | K884836 | 000 |
| 04961333241255 | K884836 | 000 |
| 04961333241262 | K884836 | 000 |
| 04961333241279 | K884836 | 000 |
| 04961333241347 | K884836 | 000 |
| 04961333241354 | K884836 | 000 |
| 04961333241361 | K884836 | 000 |
| 04961333241378 | K884836 | 000 |
| 04961333241385 | K884836 | 000 |
| 04961333241170 | K884836 | 000 |