510(k) K844234

ACTIVE VERTICAL CORRECTOR APPLIANCE by Active Vertical Correctors, Inc. — Product Code ECO

K844234 is an FDA 510(k) premarket notification submitted by Active Vertical Correctors, Inc. for the device "ACTIVE VERTICAL CORRECTOR APPLIANCE". The FDA issued a decision of Substantially Equivalent on January 4, 1985. The device falls under product code ECO (Spring, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Active Vertical Correctors, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1985
Date Received
November 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spring, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type