The following data is part of a premarket notification filed by Britt Corp., Inc. with the FDA for Model 545-45 For Neurological Surgical Application.
Device ID | K860977 |
510k Number | K860977 |
Device Name: | MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION |
Classification | Laser, Neurosurgical, Argon |
Applicant | BRITT CORP., INC. 55 KENNEDY DR. Smithtown, NY 11787 |
Contact | Jeffrey Green |
Correspondent | Jeffrey Green BRITT CORP., INC. 55 KENNEDY DR. Smithtown, NY 11787 |
Product Code | LLF |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-14 |
Decision Date | 1986-10-16 |