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510(k) K091011

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

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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