The following data is part of a premarket notification filed by Barron Precision Instruments, L.l.c. with the FDA for Barron Microkeratome System, Model B2000.
| Device ID | K983317 |
| 510k Number | K983317 |
| Device Name: | BARRON MICROKERATOME SYSTEM, MODEL B2000 |
| Classification | Keratome, Ac-powered |
| Applicant | BARRON PRECISION INSTRUMENTS, L.L.C. PO BOX 973, 8170 EMBURY RD. Grand Blanc, MI 48439 -0973 |
| Contact | Mark Barron |
| Correspondent | Mark Barron BARRON PRECISION INSTRUMENTS, L.L.C. PO BOX 973, 8170 EMBURY RD. Grand Blanc, MI 48439 -0973 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-21 |
| Decision Date | 1998-12-02 |
| Summary: | summary |