Question 1

Who is the manufacturer of DYNAREX NON-WOVEN SPONGE?

Accepted Answer

Dynarex Corp. filed the 510(k) submission for DYNAREX NON-WOVEN SPONGE (K960388).

Question 2

What is the FDA product code for DYNAREX NON-WOVEN SPONGE?

Accepted Answer

EFQ. as a Class U device in the SU panel.

Question 3

When was DYNAREX NON-WOVEN SPONGE cleared by the FDA?

Accepted Answer

Apr 1, 1996 (decision: SESE).

Question 4

What is the regulatory pathway for DYNAREX NON-WOVEN SPONGE?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DYNAREX NON-WOVEN SPONGE?

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	K960388
Device Name	DYNAREX NON-WOVEN SPONGE
Applicant	Dynarex Corp.
Product Code	EFQ · SU
Decision Date	Apr 1, 1996
Decision	SESE
Submission Type	Traditional
Device Class	Class U

DYNAREX NON-WOVEN SPONGE

Device Facts