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510(k) K961080

MEDIAL MALAR IMPLANT by Rand Scientific Corp. — Product Code LZK

K961080 is an FDA 510(k) premarket notification submitted by Rand Scientific Corp. for the device "MEDIAL MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on April 19, 1996. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Rand Scientific Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1996
Date Received
March 18, 1996
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 Rand Scientific Corp.

  • K963856 — RAND NASAL PACKING (October 18, 1996)
  • K961081 — SPIRIT RIDGE SILICONE CARVING BLOCK (May 22, 1996)
  • K955777 — PMMA CLASIC (May 16, 1996)
  • K961057 — DURALASTIC SHEETING II (May 16, 1996)
  • K961124 — THE NAUTILUS (April 19, 1996)
  • K961071 — THE MAGNUM CHIN IMPLANT (April 19, 1996)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K955366 — TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS (March 28, 1996)
  • K952165 — TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS (June 30, 1995)

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