Home / 510(k) Clearances / K981835

510(k) K981835

SILIMED MALAR IMPLANT by Silimed, LLC — Product Code LZK

K981835 is an FDA 510(k) premarket notification submitted by Silimed, LLC for the device "SILIMED MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on July 9, 1998. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Silimed, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1998
Date Received
May 26, 1998
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 Silimed, LLC

  • K042054 — SILIMED PECTORAL IMPLANT (February 23, 2005)
  • K981852 — SILIMED TISSUE EXPANDER (August 5, 1998)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K981850 — SILIMED CHIN IMPLANTS (July 9, 1998)
  • K981851 — SILIMED SILICONE CARVING BLOCK (July 9, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)
  • K980221 — SILIMED NASAL RETAINER (April 2, 1998)
  • K974482 — SILIMED GLUTEAL IMPLANT (February 24, 1998)
  • K974480 — SILIMED CALF IMPLANT (February 24, 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)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)
  • K973574 — DURALASTIC ANATOMICAL MALAR IMPLANT (October 24, 1997)

FDA data resources