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510(k) K944163

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

K944163 is an FDA 510(k) premarket notification submitted by Spectrum Designs, Inc. for the device "SPECTRUM DISIGNS PECTORAL IMPLANT". The FDA issued a decision of Substantially Equivalent on November 7, 1994. The device falls under product code MIC (Implant, Muscle, Pectoralis), a Class II device regulated under 21 CFR 874.3620. Spectrum Designs, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K980446 — SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT (May 6, 1998)
  • K980444 — SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT (May 6, 1998)
  • K980462 — SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT (May 6, 1998)
  • K980445 — SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT (May 6, 1998)
  • K980463 — SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT (May 6, 1998)
  • K980138 — SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT (April 3, 1998)
  • K980461 — SPECTRUM DESIGNS CLEFT CHIN IMPLANT (March 4, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION 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)

FDA data resources