Question 1

Who is the manufacturer of SALINE SOLUTION- STERILE?

Accepted Answer

Trinity Laboratories, Inc. filed the 510(k) submission for SALINE SOLUTION- STERILE (K922033).

Question 2

What is the FDA product code for SALINE SOLUTION- STERILE?

Accepted Answer

CCQ. It is classified under 21 CFR 868.5640 as a Class 1 device in the Anesthesiology panel.

Question 3

When was SALINE SOLUTION- STERILE cleared by the FDA?

Accepted Answer

Jul 21, 1992 (decision: SESE).

Question 4

What is the regulatory pathway for SALINE SOLUTION- STERILE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SALINE SOLUTION- STERILE?

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	K922033
Device Name	SALINE SOLUTION- STERILE
Applicant	Trinity Laboratories, Inc.
Product Code	CCQ · Anesthesiology
Decision Date	Jul 21, 1992
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5640
Device Class	Class 1

SALINE SOLUTION- STERILE

Device Facts

Regulatory Classification

Identification