The following data is part of a premarket notification filed by Cooper Medical Corp. with the FDA for Yag Laser 8000 Gastrointestinal Blee.
| Device ID | K840144 |
| 510k Number | K840144 |
| Device Name: | YAG LASER 8000 GASTROINTESTINAL BLEE |
| Classification | Biopsy Needle |
| Applicant | COOPER MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-13 |
| Decision Date | 1984-05-18 |