The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Central Vein Catheterization Tray.
Device ID | K852642 |
510k Number | K852642 |
Device Name: | CENTRAL VEIN CATHETERIZATION TRAY |
Classification | Attachment, Eyepiece, For Insertion Of Prescription Lens |
Applicant | Teleflex Medical, Inc. TALL PINES PARK Jaffrey, NH 03452 |
Contact | Herbert M Carter |
Correspondent | Herbert M Carter Teleflex Medical, Inc. TALL PINES PARK Jaffrey, NH 03452 |
Product Code | FDZ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-21 |
Decision Date | 1986-01-16 |