The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Soft Tip Needle (20 & 19 Gauges).
| Device ID | K890782 |
| 510k Number | K890782 |
| Device Name: | GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) |
| Classification | Cannula, Ophthalmic |
| Applicant | GRIESHABER & CO. 3000 CABOT BLVD. WEST P.O. BOX 1099 Langhorne, PA 19047 |
| Contact | John E Richmond |
| Correspondent | John E Richmond GRIESHABER & CO. 3000 CABOT BLVD. WEST P.O. BOX 1099 Langhorne, PA 19047 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-15 |
| Decision Date | 1989-06-23 |