The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Micro Lite Light Pipe 19 & 20 Gauge.
| Device ID | K884043 |
| 510k Number | K884043 |
| Device Name: | GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| 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 | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1988-11-16 |