510(k) K882641

TECNOL CATHETER LEG STRAP by Tecnol New Jersey Wound Care, Inc. — Product Code KNY

K882641 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL CATHETER LEG STRAP". The FDA issued a decision of Substantially Equivalent on July 12, 1988. The device falls under product code KNY (Accessories, Catheter, G-U), a Class II device regulated under 21 CFR 876.5130. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1988
Date Received
June 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type