Cleared Traditional

K792625 - STERILIZATION PROCESS/PLACENTA BASIN
(FDA 510(k) Clearance)

Jan 1980
Decision
28d
Days
Class 1
Risk

K792625 is an FDA 510(k) clearance for the STERILIZATION PROCESS/PLACENTA BASIN. This device is classified as a Basin, Emesis (Class I - General Controls, product code FNY).

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980, 28 days after receiving the submission on December 19, 1979.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6730.

Submission Details

510(k) Number K792625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1979
Decision Date January 16, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FNY — Basin, Emesis
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6730