Cleared Traditional

K855074 - FILTERED VACUUM SAFETY TRAP BOTTLE (FDA 510(k) Clearance)

Mar 1986
Decision
84d
Days
Class 2
Risk

K855074 is an FDA 510(k) clearance for the FILTERED VACUUM SAFETY TRAP BOTTLE. This device is classified as a Bottle, Collection, Vacuum (Class II - Special Controls, product code KDQ).

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 13, 1986, 84 days after receiving the submission on December 19, 1985.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K855074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1985
Decision Date March 13, 1986
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code KDQ — Bottle, Collection, Vacuum
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6740