Cleared Traditional

K801330 - ANSPACH LEG SUPPORT (FDA 510(k) Clearance)

Jun 1980
Decision
23d
Days
Class 1
Risk

K801330 is an FDA 510(k) clearance for the ANSPACH LEG SUPPORT. This device is classified as a Support, Patient Position (Class I - General Controls, product code CCX).

Submitted by The Anspach Effort, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1980, 23 days after receiving the submission on June 3, 1980.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.6820.

Submission Details

510(k) Number K801330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date June 26, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code CCX — Support, Patient Position
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.6820