The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Modified Site Power Handpiece.
| Device ID | K922077 |
| 510k Number | K922077 |
| Device Name: | MODIFIED SITE POWER HANDPIECE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | CHIRON VISION CORP. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Contact | Brnt Miller |
| Correspondent | Brnt Miller CHIRON VISION CORP. 135 GIBRALTAR RD. Horsham, PA 19044 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-04 |
| Decision Date | 1992-06-23 |