The following data is part of a premarket notification filed by Biophysic Medical, Inc. with the FDA for Sterile Disposable Endocular Probe.
| Device ID | K884456 |
| 510k Number | K884456 |
| Device Name: | STERILE DISPOSABLE ENDOCULAR PROBE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOPHYSIC MEDICAL, INC. 2440 ESTAND WAY Pleasant Hill, CA 94523 |
| Contact | Douglas Donaldson |
| Correspondent | Douglas Donaldson BIOPHYSIC MEDICAL, INC. 2440 ESTAND WAY Pleasant Hill, CA 94523 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-24 |
| Decision Date | 1988-12-09 |