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510(k) K945537

T-GUARD by Med ET AL Development — Product Code LQX

K945537 is an FDA 510(k) premarket notification submitted by Med ET AL Development for the device "T-GUARD". The FDA issued a decision of Substantially Equivalent on March 23, 1995. The device falls under product code LQX (Device, Finger-Sucking), a Class I device regulated under 21 CFR 890.3475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1995
Date Received
November 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Finger-Sucking
Device Class
Class I
Regulation Number
890.3475
Review Panel
DE
Submission Type

Other clearances for product code LQX

  • K864870 — THUMBSHELPER POWER RING (February 12, 1987)

FDA data resources