Question 1

Who is the manufacturer of CONTROL SYRINGE?

Accepted Answer

Louisville Laboratories, Inc. filed the 510(k) submission for CONTROL SYRINGE (K960882).

Question 2

What is the FDA product code for CONTROL SYRINGE?

Accepted Answer

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

Question 3

When was CONTROL SYRINGE cleared by the FDA?

Accepted Answer

Jul 8, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for CONTROL SYRINGE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like CONTROL SYRINGE?

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	K960882
Device Name	CONTROL SYRINGE
Applicant	Louisville Laboratories, Inc.
Product Code	FMF · General Hospital
Decision Date	Jul 8, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2

CONTROL SYRINGE

Device Facts

Regulatory Classification

Identification