The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Air System/pressure Ophthalmic Irrigant.
| Device ID | K864056 |
| 510k Number | K864056 |
| Device Name: | GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT |
| Classification | Unit, Phacofragmentation |
| Applicant | GRIESHABER & CO. 1056 TRENTON RD. P.O. BOX 807 Fallisington, PA 19054 |
| Contact | John E Richmond |
| Correspondent | John E Richmond GRIESHABER & CO. 1056 TRENTON RD. P.O. BOX 807 Fallisington, PA 19054 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-15 |
| Decision Date | 1986-10-31 |