The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Model J25-25 Watt Co2 Laser.
| Device ID | K851425 |
| 510k Number | K851425 |
| Device Name: | MODEL J25-25 WATT CO2 LASER |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | BRITT CORP., INC. 2231 SOUTH BARRINGTON AVE. Los Angeles, CA 90064 |
| Contact | John J Mcdonald |
| Correspondent | John J Mcdonald BRITT CORP., INC. 2231 SOUTH BARRINGTON AVE. Los Angeles, CA 90064 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-10 |
| Decision Date | 1985-11-12 |