510(k) K884440

TECNOL VARIABLE TENSION BANDAGE by Tecnol New Jersey Wound Care, Inc. — Product Code NAD

K884440 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL VARIABLE TENSION BANDAGE". The FDA issued a decision of SN on January 17, 1989. The device falls under product code NAD (Dressing, Wound, Occlusive), a Class I device regulated under 21 CFR 878.4020. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
January 17, 1989
Date Received
October 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type