The following data is part of a premarket notification filed by Escalon Trek Medical with the FDA for Autopole Regulator System.
| Device ID | K924999 |
| 510k Number | K924999 |
| Device Name: | AUTOPOLE REGULATOR SYSTEM |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | ESCALON TREK MEDICAL 182 TAMARACK CIRCLE Skillman, NJ 08558 |
| Contact | Ronald Hueneke |
| Correspondent | Ronald Hueneke ESCALON TREK MEDICAL 182 TAMARACK CIRCLE Skillman, NJ 08558 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-02 |
| Decision Date | 1992-12-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853480006143 | K924999 | 000 |
| 00853480006136 | K924999 | 000 |