Question 1

Who is the manufacturer of HEALTHPAK UTILITY SOX BARRIERS?

Accepted Answer

Healthpak, Inc. filed the 510(k) submission for HEALTHPAK UTILITY SOX BARRIERS (K923306).

Question 2

What is the FDA product code for HEALTHPAK UTILITY SOX BARRIERS?

Accepted Answer

KLC. It is classified under 21 CFR 872.6250 as a Class 1 device in the Dental panel.

Question 3

When was HEALTHPAK UTILITY SOX BARRIERS cleared by the FDA?

Accepted Answer

Aug 5, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for HEALTHPAK UTILITY SOX BARRIERS?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HEALTHPAK UTILITY SOX BARRIERS?

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	K923306
Device Name	HEALTHPAK UTILITY SOX BARRIERS
Applicant	Healthpak, Inc.
Product Code	KLC · Dental
Decision Date	Aug 5, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6250
Device Class	Class 1

HEALTHPAK UTILITY SOX BARRIERS

Device Facts

Regulatory Classification

Identification