Home / 510(k) Clearances / K944163

510(k) K944163

SPECTRUM DISIGNS PECTORAL IMPLANT by Spectrum Designs, Inc. — Product Code MIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1994
Date Received
August 26, 1994
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 Spectrum Designs, Inc.

  • K992522 — SPECTRUM DESIGNS SPECTRAGEL (October 26, 1999)
  • K982688 — SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK (October 13, 1998)
  • K980444 — SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT (May 6, 1998)
  • K980463 — SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT (May 6, 1998)
  • K980446 — SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT (May 6, 1998)
  • K980445 — SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT (May 6, 1998)
  • K980462 — SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT (May 6, 1998)
  • K980138 — SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT (April 3, 1998)
  • K980461 — SPECTRUM DESIGNS CLEFT CHIN IMPLANT (March 4, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)

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)
  • K913768 — PEC IMPLANT (February 3, 1992)