The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Model 545-45 Laser For Ear, Nose & Throat.
| Device ID | K860975 |
| 510k Number | K860975 |
| Device Name: | MODEL 545-45 LASER FOR EAR, NOSE & THROAT |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | BRITT CORP., INC. 2231 SOUTH BARRINGTON AVE. Los Angeles, CA 90064 |
| Contact | Jeffrey Green |
| Correspondent | Jeffrey Green BRITT CORP., INC. 2231 SOUTH BARRINGTON AVE. Los Angeles, CA 90064 |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-14 |
| Decision Date | 1986-07-18 |