Cleared Traditional

WATER JEL BURN KIT

K952561 · Water-Jel Technologies, Inc. · General & Plastic Surgery

Jul 1995

Decision

42d

Days

—

Risk

About This 510(k) Submission

K952561 is an FDA 510(k) clearance for the WATER JEL BURN KIT, a First Aid Kit With Drug, submitted by Water-Jel Technologies, Inc. (Carlstadt, US). The FDA issued a Cleared decision on July 14, 1995, 42 days after receiving the submission on June 2, 1995. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K952561 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1995
Decision Date	July 14, 1995
Days to Decision	42 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	LRR — First Aid Kit With Drug
Device Class	—
Definition	Note: In Addition To Compliance With Our Convenience Kit Guidance, In Regards To Any Drug Products Contained In This Kit Compliance With The Center For Drug Evaluation Is Required As Well. Www.fda.gov/cder/index.html - This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.