Cleared Traditional

PEC IMPLANT

K961072 · Rand Scientific Corp. · General & Plastic Surgery
Apr 1996
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K961072 is an FDA 510(k) clearance for the PEC IMPLANT, a Implant, Muscle, Pectoralis (Class II — Special Controls, product code MIC), submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on April 19, 1996, 32 days after receiving the submission on March 18, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K961072 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1996
Decision Date April 19, 1996
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code MIC — Implant, Muscle, Pectoralis
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620

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