The following data is part of a premarket notification filed by Microline Pentax, Inc. with the FDA for Microline Cat #100.
| Device ID | K880943 |
| 510k Number | K880943 |
| Device Name: | MICROLINE CAT #100 |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MICROLINE PENTAX, INC. 199 NEWBURY ST. Devers, MA 01923 |
| Contact | De Laforcade |
| Correspondent | De Laforcade MICROLINE PENTAX, INC. 199 NEWBURY ST. Devers, MA 01923 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-07 |
| Decision Date | 1988-05-26 |