The following data is part of a premarket notification filed by Dgh Technology, Inc. with the FDA for Dgh Model 9000.
| Device ID | K965127 |
| 510k Number | K965127 |
| Device Name: | DGH MODEL 9000 |
| Classification | Unit, Phacofragmentation |
| Applicant | DGH TECHNOLOGY, INC. 110 SUMMIT DR., SUITE B Exton, PA 19341 |
| Contact | Earl W Henderson |
| Correspondent | Earl W Henderson DGH TECHNOLOGY, INC. 110 SUMMIT DR., SUITE B Exton, PA 19341 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-03-17 |