The following data is part of a premarket notification filed by Chalgren Enterprises, Inc. with the FDA for Disposable Hypodermic Monoplar Needle Recording.
| Device ID | K924277 |
| 510k Number | K924277 |
| Device Name: | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING |
| Classification | Preamplifier, Ac-powered, Ophthalmic |
| Applicant | CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Contact | Richard Kaiser |
| Correspondent | Richard Kaiser CHALGREN ENTERPRISES, INC. 8021 CARMEL ST. SUITE B Gilroy, CA 95020 |
| Product Code | HLT |
| CFR Regulation Number | 886.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-25 |
| Decision Date | 1994-12-07 |