510(k) K760308

I.V. SUPPORT, TECNOL ARMBOARD by Tecnol New Jersey Wound Care, Inc. — Product Code FSE

K760308 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "I.V. SUPPORT, TECNOL ARMBOARD". The FDA issued a decision of Substantially Equivalent on August 11, 1976. The device falls under product code FSE (Table, Operating-Room, Manual), a Class I device regulated under 21 CFR 878.4950. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Manual
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type