Question 1

Who is the manufacturer of EPI 2?

Accepted Answer

Universal H.R. System, Inc. filed the 510(k) submission for EPI 2 (K935706).

Question 2

What is the FDA product code for EPI 2?

Accepted Answer

KCX. It is classified under 21 CFR 878.5360 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was EPI 2 cleared by the FDA?

Accepted Answer

Feb 11, 1997 (decision: SESE).

Question 4

What is the regulatory pathway for EPI 2?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like EPI 2?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K935706
Device Name	EPI 2
Applicant	Universal H.R. System, Inc.
Product Code	KCX · General, Plastic Surgery
Decision Date	Feb 11, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5360
Device Class	Class 1

EPI 2

Device Facts

Regulatory Classification

Identification