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510(k) K955528

CLP BONNET by Clp Products — Product Code DZB

K955528 is an FDA 510(k) premarket notification submitted by Clp Products for the device "CLP BONNET". The FDA issued a decision of Substantially Equivalent on February 14, 1996. The device falls under product code DZB (Headgear, Extraoral, Orthodontic), a Class II device regulated under 21 CFR 872.5500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1996
Date Received
December 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

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  • K000358 — MULTI ADJUSTABLE FACE MASK (June 9, 2000)
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FDA data resources