The following data is part of a premarket notification filed by Geuder Gmbh with the FDA for Geuder Injector For Morcher Capsular Tension Ring.
| Device ID | K001125 |
| 510k Number | K001125 |
| Device Name: | GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING |
| Classification | Injector, Capsular Tension Ring |
| Applicant | GEUDER GMBH 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
| Contact | Hillard W Welch |
| Correspondent | Hillard W Welch GEUDER GMBH 344 ANNABELLE POINT RD. Centerville, MA 02632 -2402 |
| Product Code | NCE |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-07 |
| Decision Date | 2000-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049368128182 | K001125 | 000 |
| 04049368128113 | K001125 | 000 |
| 04049368128083 | K001125 | 000 |