meddevicedb.com FDA Device Reference

THE 3PM EGG MACHINE

DEN990005 Class II Post-NSE
Decision Date
1999-08-20
Sponsor / Applicant
3pm Co., Inc.

Technical Specification

510(k) Submission ID DEN990005
Product Code MYE
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.1735
Decision Date 1999-08-20
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

THE 3PM EGG MACHINE received FDA 510(k) clearance under submission number DEN990005, sponsored by 3pm Co., Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1999-08-20.

Classification & Regulation

This clearance is catalogued under FDA product code MYE and 21 CFR 876.1735, within the Gastroenterology, Urology review panel as a Class II device.