The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Telet-lex Medical Iv Catheter Placement.
Device ID | K851142 |
510k Number | K851142 |
Device Name: | TELET-LEX MEDICAL IV CATHETER PLACEMENT |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
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 | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-21 |
Decision Date | 1985-07-05 |