The following data is part of a premarket notification filed by Tecnol New Jersey Wound Care, Inc. with the FDA for I.v. Support, Tecnol Armboard.
Device ID | K760308 |
510k Number | K760308 |
Device Name: | I.V. SUPPORT, TECNOL ARMBOARD |
Classification | Table, Operating-room, Manual |
Applicant | TECNOL NEW JERSEY WOUND CARE, INC. 368 FAIRVIEW AVE. Hammonton, NJ 08037 -0268 |
Product Code | FSE |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-26 |
Decision Date | 1976-08-11 |