Cleared Traditional

K760490 - BEDPAN, GENERAL MEDICAL MEDI-PAK
(FDA 510(k) Clearance)

Nov 1976
Decision
81d
Days
Class 1
Risk

K760490 is an FDA 510(k) clearance for the BEDPAN, GENERAL MEDICAL MEDI-PAK. This device is classified as a Bedpan (Class I - General Controls, product code FOB).

Submitted by Landmark Plastics (Mchenry, US). The FDA issued a Cleared decision on November 12, 1976, 81 days after receiving the submission on August 23, 1976.

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

Submission Details

510(k) Number K760490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1976
Decision Date November 12, 1976
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FOB — Bedpan
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6730