PEC IMPLANT— 510(k) K961072

Substantially Equivalent

Rand Scientific Corp.

FDA 510(k) clearance K961072 for PEC IMPLANT, Substantially Equivalent on 1996-04-19. Applicant: Rand Scientific Corp.. Device class: 2.

Clearance details

Applicant: Rand Scientific Corp.
Product code: Code MIC
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1996-03-18
Decision date: 1996-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIC

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K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT1998-09-30
K983043 — SEARE BIOMEDICAL SILICONE BLOCK1998-09-30
K973729 — POWERFLEX PEC IMPLANT1997-12-24

More clearances from Rand Scientific Corp.

K963856 — RAND NASAL PACKING1996-10-18
K961081 — SPIRIT RIDGE SILICONE CARVING BLOCK1996-05-22
K955777 — PMMA CLASIC1996-05-16
K961057 — DURALASTIC SHEETING II1996-05-16
K961071 — THE MAGNUM CHIN IMPLANT1996-04-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.