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510(k) K973575

DURALASTIC ANATOMICAL CHIN IMPLANTS by Hanson Medical, Inc. — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1997
Date Received
September 19, 1997
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

Other clearances by Hanson Medical, Inc.

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  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K030809 — HANSON MEDICAL GLUTEAL IMPLANT (April 21, 2003)
  • K030808 — HANSON MEDICAL CALF IMPLANT (April 21, 2003)
  • K973729 — POWERFLEX PEC IMPLANT (December 24, 1997)
  • K973730 — DURASIL I AND DURASIL II (December 24, 1997)
  • K973573 — DURALASTIC ANATOMICAL NASAL IMPLANTS (November 13, 1997)

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