Cleared Traditional

K931607 - MEDDRAINS
(FDA 510(k) Clearance)

K931607 · Armm, Inc. · General & Plastic Surgery device
Aug 1993
Decision
127d
Days
Class 1
Risk

K931607 is an FDA 510(k) clearance for the MEDDRAINS. This device is classified as a Catheter, Pediatric, General & Plastic Surgery (Class I - General Controls, product code GBN).

Submitted by Armm, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on August 6, 1993, 127 days after receiving the submission on April 1, 1993.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K931607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1993
Decision Date August 06, 1993
Days to Decision 127 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GBN — Catheter, Pediatric, General & Plastic Surgery
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4200