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510(k) K944165

SILHOUETTE MALAR IMPLANT by Spectrum Designs, Inc. — Product Code LZK

K944165 is an FDA 510(k) premarket notification submitted by Spectrum Designs, Inc. for the device "SILHOUETTE MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on November 4, 1994. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Spectrum Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1994
Date Received
August 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Malar
Device Class
Class II
Regulation Number
878.3550
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)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)

Other clearances for product code LZK

  • K021419 — AART MALAR IMPLANT (July 2, 2002)
  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)

FDA data resources