The following data is part of a premarket notification filed by Microline Pentax, Inc. with the FDA for Bradbury Intraocular Retinal Kit Cat #200.
| Device ID | K881049 |
| 510k Number | K881049 |
| Device Name: | BRADBURY INTRAOCULAR RETINAL KIT CAT #200 |
| Classification | Forceps, Ophthalmic |
| 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 | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-11 |
| Decision Date | 1988-09-12 |