Cleared Traditional

STERILIZATION PROCESS/OUTERWRAP

K792633 · Procter & Gamble Mfg. Co. · Pathology
Jan 1980
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K792633 is an FDA 510(k) clearance for the STERILIZATION PROCESS/OUTERWRAP, a Filters, Cell Collection, Tissue Processing (Class I — General Controls, product code KET), submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980, 23 days after receiving the submission on December 19, 1979. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K792633 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1979
Decision Date January 11, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KET — Filters, Cell Collection, Tissue Processing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010