Cleared Traditional

K922918 - BARRIER SAF-TE HYDROGEL DRAPE
(FDA 510(k) Clearance)

K922918 · Johnson & Johnson International · General Hospital

Jul 1993

Decision

383d

Days

Class 2

Risk

K922918 is an FDA 510(k) clearance for the BARRIER SAF-TE HYDROGEL DRAPE. This device is classified as a Drape, Surgical (Class II — Special Controls, product code KKX).

Submitted by Johnson & Johnson International (Arlington, US). The FDA issued a Cleared decision on July 6, 1993, 383 days after receiving the submission on June 18, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K922918 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 1992
Decision Date	July 06, 1993
Days to Decision	383 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF