The following data is part of a premarket notification filed by Microline Pentax, Inc. with the FDA for Intraocular Microscissors By Means Of Gamma Radia..
| Device ID | K897093 |
| 510k Number | K897093 |
| Device Name: | INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA. |
| Classification | Scissors, 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 | HNF |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-20 |
| Decision Date | 1990-04-04 |