Question 1

Who is the manufacturer of EXPANDACELL INJECTO-PAK NASAL PACK?

Accepted Answer

Shippert Medical Technologies Corp. filed the 510(k) submission for EXPANDACELL INJECTO-PAK NASAL PACK (K954845).

Question 2

What is the FDA product code for EXPANDACELL INJECTO-PAK NASAL PACK?

Accepted Answer

EMX. It is classified under 21 CFR 874.4100 as a Class 1 device in the Ear, Nose, Throat panel.

Question 3

When was EXPANDACELL INJECTO-PAK NASAL PACK cleared by the FDA?

Accepted Answer

Nov 27, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for EXPANDACELL INJECTO-PAK NASAL PACK?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like EXPANDACELL INJECTO-PAK NASAL PACK?

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	K954845
Device Name	EXPANDACELL INJECTO-PAK NASAL PACK
Applicant	Shippert Medical Technologies Corp.
Product Code	EMX · Ear, Nose, Throat
Decision Date	Nov 27, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4100
Device Class	Class 1

EXPANDACELL INJECTO-PAK NASAL PACK

Device Facts

Regulatory Classification

Identification