The following data is part of a premarket notification filed by Sauquoit Industries, Inc. with the FDA for Dtl Electrode.
| Device ID | K844409 |
| 510k Number | K844409 |
| Device Name: | DTL ELECTRODE |
| Classification | Electrode, Corneal |
| Applicant | SAUQUOIT INDUSTRIES, INC. P.O. BOX 1279, 300 PALM STREET SCRANTON, PA 18501 |
| Contact | JOHN SCOFIELD |
| Correspondent | JOHN SCOFIELD SAUQUOIT INDUSTRIES, INC. P.O. BOX 1279, 300 PALM STREET SCRANTON, PA 18501 |
| Product Code | HLZ |
| CFR Regulation Number | 886.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-14 |
| Decision Date | 1985-02-14 |