Cleared Traditional

K772405 - TUBING CLAMP
(FDA 510(k) Clearance)

Jan 1978
Decision
30d
Days
Class 1
Risk

K772405 is an FDA 510(k) clearance for the TUBING CLAMP. This device is classified as a Clamp, Non-electrical (Class I - General Controls, product code FFN).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1978, 30 days after receiving the submission on December 27, 1977.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K772405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date January 26, 1978
Days to Decision 30 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code FFN — Clamp, Non-electrical
Device Class Class I - General Controls
CFR Regulation 21 CFR 876.4730