The following data is part of a premarket notification filed by Pmt, Inc. with the FDA for Pmt-optica Line.
| Device ID | K831118 |
| 510k Number | K831118 |
| Device Name: | PMT-OPTICA LINE |
| Classification | Instrument, Surgical, Disposable |
| Applicant | PMT, Inc. Box 464 Hopkins, MN 55343 |
| Contact | Alfred A Iversen |
| Correspondent | Alfred A Iversen PMT, Inc. Box 464 Hopkins, MN 55343 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-05 |
| Decision Date | 1984-01-25 |