The following data is part of a premarket notification filed by Doran Instruments, Inc. with the FDA for Goldlens(tm).
| Device ID | K913239 |
| 510k Number | K913239 |
| Device Name: | GOLDLENS(TM) |
| Classification | Electrode, Corneal |
| Applicant | DORAN INSTRUMENTS, INC. 410 GREAT RD. P.O. BOX 1070 Littleton, MA 01460 |
| Contact | Bruce Doran |
| Correspondent | Bruce Doran DORAN INSTRUMENTS, INC. 410 GREAT RD. P.O. BOX 1070 Littleton, MA 01460 |
| Product Code | HLZ |
| CFR Regulation Number | 886.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1992-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850594007011 | K913239 | 000 |
| 00855730007337 | K913239 | 000 |
| 00855730007320 | K913239 | 000 |