Cleared Traditional

K952470 - ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.
(FDA 510(k) Clearance)

K952470 · R-Group Intl. · General & Plastic Surgery device

Nov 1995

Decision

186d

Days

Class 1

Risk

K952470 is an FDA 510(k) clearance for the ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.. This device is classified as a Connector, Catheter (Class I - General Controls, product code GCD).

Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on November 28, 1995, 186 days after receiving the submission on May 26, 1995.

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

Submission Details

510(k) Number	K952470 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 26, 1995
Decision Date	November 28, 1995
Days to Decision	186 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF