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510(k) K961072

PEC IMPLANT by Rand Scientific Corp. — Product Code MIC

K961072 is an FDA 510(k) premarket notification submitted by Rand Scientific Corp. for the device "PEC IMPLANT". The FDA issued a decision of Substantially Equivalent on April 19, 1996. The device falls under product code MIC (Implant, Muscle, Pectoralis), a Class II device regulated under 21 CFR 874.3620. 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, Muscle, Pectoralis
Device Class
Class II
Regulation Number
874.3620
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)
  • K961080 — MEDIAL MALAR 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 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)
  • K944163 — SPECTRUM DISIGNS PECTORAL IMPLANT (November 7, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)

FDA data resources