Cleared Traditional

K935531 - OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
(FDA 510(k) Clearance)

K935531 · Puritas Health Care, Inc. · General & Plastic Surgery

May 1994

Decision

170d

Days

Class 1

Risk

K935531 is an FDA 510(k) clearance for the OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP. This device is classified as a Catheter, Irrigation (Class I — General Controls, product code GBX).

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on May 5, 1994, 170 days after receiving the submission on November 16, 1993.

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

Submission Details

510(k) Number	K935531 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 1993
Decision Date	May 05, 1994
Days to Decision	170 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement