510(k) K932184

STERILE LEMAITRE GLOW 'N TELL TAPE by Vascutech, Inc. — Product Code KFX

K932184 is an FDA 510(k) premarket notification submitted by Vascutech, Inc. for the device "STERILE LEMAITRE GLOW 'N TELL TAPE". The FDA issued a decision of Substantially Equivalent on July 22, 1993. The device falls under product code KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External), a Class II device regulated under 21 CFR 890.3500. Vascutech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1993
Date Received
May 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device Class
Class II
Regulation Number
890.3500
Review Panel
PM
Submission Type