Device Atlas

The Expandacell Ear Pack

Q: What is the product code of K940133?

The FDA product code is LRD – Applicator, Ent Drug, a Class I (low risk) device regulated under 21 CFR 874.5220.

FDA 510(k) K940133 · Denver Splint Co.

Substantially Equivalent

510(k) numberK940133

Submission

Device name: The Expandacell Ear Pack
Applicant: Denver Splint Co.
Englewood, CO, US
Received: January 3, 1994
Decision date: May 23, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LRD – Applicator, Ent Drug
Device class: Class I (low risk)
Regulation: 21 CFR 874.5220
Specialty: Ear, Nose, Throat

Other 510(k)s with product code LRD

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K984345	AromapatchLRD · Traditional	Envis, Inc.	03/19/1999SE
K932522	Amsco Sterile Recoveries Surgical PacksLRD · Traditional	Amsco Sterile Recoveries, Inc.	09/09/1994SE
K942789	MistassistLRD · Traditional	The Merlin Corp.	08/12/1994SE
K925022	Surgical Tray (Sterile)LRD · Traditional	Customed, Inc.	04/26/1993SE
K920842	Aerosol Delivery SystemsLRD · Traditional	Hospitak, Inc.	05/15/1992SE

More from Hospitak, Inc.

510(k)	Device	Decision
K940798	Shippert Pressure BandageKGX · Traditional	09/28/1994SE
K935724	The Expandacell Sinus PackEMX · Traditional	05/12/1994SE
K922062	The Denver CauteryGEI · Traditional	01/12/1993SE

Questions and answers

When was The Expandacell Ear Pack cleared by the FDA?

The Expandacell Ear Pack (K940133) received a 510(k) decision of Substantially Equivalent on May 23, 1994, 140 days after the submission was received.

What is the product code of K940133?

The FDA product code is LRD – Applicator, Ent Drug, a Class I (low risk) device regulated under 21 CFR 874.5220.