The following data is part of a premarket notification filed by None with the FDA for Pulmonary Vein Clamp.
Device ID | K852479 |
510k Number | K852479 |
Device Name: | PULMONARY VEIN CLAMP |
Classification | Clamp, Vascular |
Applicant | NONE 7930 FROST ST., SUITE 305 San Diego, CA 92123 |
Contact | Daily, M.d. |
Correspondent | Daily, M.d. NONE 7930 FROST ST., SUITE 305 San Diego, CA 92123 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-11 |
Decision Date | 1985-08-09 |