The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Centermark Securing Wings.
Device ID | K940127 |
510k Number | K940127 |
Device Name: | CENTERMARK SECURING WINGS |
Classification | Device, Intravascular Catheter Securement |
Applicant | MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
Contact | Thom Lawson |
Correspondent | Thom Lawson MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-10 |
Decision Date | 1994-02-09 |