Sealouette Fibrin Sealant Extended Droplet Applicator, Model TE-1

Q: What is the product code of K000048?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.

FDA 510(k) K000048 · Biosurgical Corp.

Substantially Equivalent

510(k) numberK000048

Submission

Device name: Sealouette Fibrin Sealant Extended Droplet Applicator, Model TE-1
Applicant: Biosurgical Corp.
Pleasanton, CA, US
Received: January 7, 2000
Decision date: January 31, 2000
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FMF – Syringe, Piston
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5860
Specialty: General Hospital

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More from Instylla, Inc.

510(k)	Device	Decision
K000438	Multi Lumen Suction Syringe Spray DispenserFMF · Traditional	05/03/2000SE
K992351	Sealouette Fibrin Sealant ApplicatorFMF · Traditional	10/08/1999SE
K964597	Biosurgical, Corp. Multi Chamber Suction SyringeFMF · Traditional	09/08/1997SE

Questions and answers

When was Sealouette Fibrin Sealant Extended Droplet Applicator, Model TE-1 cleared by the FDA?

Sealouette Fibrin Sealant Extended Droplet Applicator, Model TE-1 (K000048) received a 510(k) decision of Substantially Equivalent on January 31, 2000, 24 days after the submission was received.

What is the product code of K000048?

The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.