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510(k) K952705

SPIRIT RIDGE NASAL IMPLANT by Spirit Ridge Technologies — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1995
Date Received
June 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type

Other clearances by Spirit Ridge Technologies

  • K952707 — SILICONE ELASTOMER MALAR IMPLANT (August 28, 1995)
  • K952709 — PROTHESIS, CHIN, INTERNAL (August 28, 1995)
  • K952706 — SPIRIT RIDGE SILICONE CARVING BLOCK (August 28, 1995)
  • K952708 — PECTORALIS IMPLANT (August 28, 1995)

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  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)