The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for The Grieshaber Axial Cutter.
| Device ID | K950056 |
| 510k Number | K950056 |
| Device Name: | THE GRIESHABER AXIAL CUTTER |
| Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Applicant | GRIESHABER & CO. 1945 VAUGHN RD. P.O. BOX 440609 Kennesaw, GA 30144 |
| Contact | Frank J Tighe |
| Correspondent | Frank J Tighe GRIESHABER & CO. 1945 VAUGHN RD. P.O. BOX 440609 Kennesaw, GA 30144 |
| Product Code | HKP |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-06 |
| Decision Date | 1995-05-05 |