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510(k) K913768

PEC IMPLANT by Applied Biomaterial Technologies — Product Code MIC

K913768 is an FDA 510(k) premarket notification submitted by Applied Biomaterial Technologies for the device "PEC IMPLANT". The FDA issued a decision of Substantially Equivalent on February 3, 1992. The device falls under product code MIC (Implant, Muscle, Pectoralis), a Class II device regulated under 21 CFR 874.3620. Applied Biomaterial Technologies has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1992
Date Received
August 22, 1991
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 Applied Biomaterial Technologies

  • K935571 — DURALASTIC SHEETING (January 31, 1995)
  • K945552 — DURALASTIC SHEETING (January 31, 1995)
  • K931500 — THE PERMARIDGE MATRIX CHIN (November 17, 1994)
  • K902285 — THE MAGNUM CHIN IMPLANT (September 12, 1990)
  • K902284 — ZYMALAR IMPLANT (September 12, 1990)
  • K902283 — THE NAUTILUS NASAL IMPLANT (August 14, 1990)

Other clearances for product code MIC

  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K983043 — SEARE BIOMEDICAL SILICONE BLOCK (September 30, 1998)
  • K973729 — POWERFLEX PEC IMPLANT (December 24, 1997)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K944163 — SPECTRUM DISIGNS PECTORAL IMPLANT (November 7, 1994)

FDA data resources