Question 1

Who is the manufacturer of NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY?

Accepted Answer

Kleen Test Products filed the 510(k) submission for NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY (K801256).

Question 2

What is the FDA product code for NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY?

Accepted Answer

BXX. It is classified under 21 CFR 868.2620 as a Class 1 device in the Anesthesiology panel.

Question 3

When was NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY cleared by the FDA?

Accepted Answer

Jun 4, 1980 (decision: SESE).

Question 4

What is the regulatory pathway for NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY?

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	K801256
Device Name	NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY
Applicant	Kleen Test Products
Product Code	BXX · Anesthesiology
Decision Date	Jun 4, 1980
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2620
Device Class	Class 1

NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY

Device Facts

Regulatory Classification

Identification