The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Aspirating Endo Ocular Probe W/illumination.
| Device ID | K921488 |
| 510k Number | K921488 |
| Device Name: | ASPIRATING ENDO OCULAR PROBE W/ILLUMINATION |
| Classification | Cannula, Ophthalmic |
| Applicant | SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Contact | Alan T Beckman |
| Correspondent | Alan T Beckman SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
| Product Code | HMX |
| Subsequent Product Code | EQH |
| Subsequent Product Code | HQE |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-30 |
| Decision Date | 1992-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10380657504265 | K921488 | 000 |