Sterile Lemaitre Glow 'N Tell Tape

FDA 510(k) K932184 · Vascutech, Inc.

Substantially Equivalent

510(k) numberK932184

Submission

Device name
Sterile Lemaitre Glow 'N Tell Tape
Applicant
Vascutech, Inc.
North Andover, MA, US
Received
May 5, 1993
Decision date
July 22, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3500
Specialty
Physical Medicine

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K833868Ipos G.L.P. SystemKFX · Traditional Ipos Luneburg11/28/1983SE
K830285Regnell Hydraulic Femoral ProthesisKFX · Traditional Besco Financial Service03/09/1983SE
K822240Ethylene Oxide Steriliz. Parametric Rel.KFX · Traditional American Mcgaw12/30/1982SE

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Questions and answers

When was Sterile Lemaitre Glow 'N Tell Tape cleared by the FDA?

Sterile Lemaitre Glow 'N Tell Tape (K932184) received a 510(k) decision of Substantially Equivalent on July 22, 1993, 78 days after the submission was received.

What is the product code of K932184?

The FDA product code is KFX – Assembly, Thigh/Knee/Shank/Ankle/Foot, External, a Class II (moderate risk) device regulated under 21 CFR 890.3500.