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510(k) K091011

PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER) by Surgical Technology Laboratories, Inc ("Stl") — Product Code FWP

K091011 is an FDA 510(k) premarket notification submitted by Surgical Technology Laboratories, Inc ("Stl") for the device "PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)". The FDA issued a decision of Substantially Equivalent on April 22, 2009. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2009
Date Received
April 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

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FDA data resources