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510(k) K021337

AART PECTORALIS IMPLANT by Aesthetic and Reconstructive Technologies, Inc. — Product Code MIC

K021337 is an FDA 510(k) premarket notification submitted by Aesthetic and Reconstructive Technologies, Inc. for the device "AART PECTORALIS IMPLANT". The FDA issued a decision of Substantially Equivalent on July 3, 2002. The device falls under product code MIC (Implant, Muscle, Pectoralis), a Class II device regulated under 21 CFR 874.3620. Aesthetic and Reconstructive Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2002
Date Received
April 26, 2002
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 Aesthetic and Reconstructive Technologies, Inc.

  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K022511 — AART CALF IMPLANT (August 26, 2002)
  • K022223 — AART SILICONE SHEETING (August 8, 2002)
  • K021839 — AART GLUTEAL IMPLANT (July 16, 2002)
  • K021820 — AART SILICONE CARVING BLOCK (July 16, 2002)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K021417 — AART CHIN IMPLANT (July 2, 2002)

Other clearances for product code MIC

  • K002633 — SILMAX PECTORAL IMPLANT (November 21, 2000)
  • K983043 — SEARE BIOMEDICAL SILICONE BLOCK (September 30, 1998)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K973729 — POWERFLEX PEC IMPLANT (December 24, 1997)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K944163 — SPECTRUM DISIGNS PECTORAL IMPLANT (November 7, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)

FDA data resources