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510(k) K973729

POWERFLEX PEC IMPLANT by Hanson Medical, Inc. — Product Code MIC

K973729 is an FDA 510(k) premarket notification submitted by Hanson Medical, Inc. for the device "POWERFLEX PEC IMPLANT". The FDA issued a decision of Substantially Equivalent on December 24, 1997. The device falls under product code MIC (Implant, Muscle, Pectoralis), a Class II device regulated under 21 CFR 874.3620. Hanson Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 1997
Date Received
September 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Muscle, Pectoralis
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type

Other clearances by Hanson Medical, Inc.

  • K141822 — SENSEI X ROBOTIC CATHETER SYSTEM (August 5, 2014)
  • K090803 — HANSON MEDICAL FACIAL IMPLANTS (June 30, 2010)
  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K040307 — HANSON SCAR ADE (August 12, 2004)
  • K030808 — HANSON MEDICAL CALF IMPLANT (April 21, 2003)
  • K030809 — HANSON MEDICAL GLUTEAL IMPLANT (April 21, 2003)
  • K973730 — DURASIL I AND DURASIL II (December 24, 1997)
  • K973573 — DURALASTIC ANATOMICAL NASAL IMPLANTS (November 13, 1997)
  • K973728 — SILICONE CARVING BLOCK (November 13, 1997)

Other clearances for product code MIC

  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K983043 — SEARE BIOMEDICAL SILICONE BLOCK (September 30, 1998)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K944163 — SPECTRUM DISIGNS PECTORAL IMPLANT (November 7, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)

FDA data resources