Question 1

Who is the manufacturer of DELUXE MAGMAG BREAST PUMP?

Accepted Answer

Pigeon Corp. filed the 510(k) submission for DELUXE MAGMAG BREAST PUMP (K936309).

Question 2

What is the FDA product code for DELUXE MAGMAG BREAST PUMP?

Accepted Answer

HGX. It is classified under 21 CFR 884.5160 as a Class 2 device in the Obstetrics/Gynecology panel.

Question 3

When was DELUXE MAGMAG BREAST PUMP cleared by the FDA?

Accepted Answer

Nov 30, 1994 (decision: SESE).

Question 4

What is the regulatory pathway for DELUXE MAGMAG BREAST PUMP?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DELUXE MAGMAG BREAST PUMP?

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	K936309
Device Name	DELUXE MAGMAG BREAST PUMP
Applicant	Pigeon Corp.
Product Code	HGX · Obstetrics/Gynecology
Decision Date	Nov 30, 1994
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.5160
Device Class	Class 2

DELUXE MAGMAG BREAST PUMP

Device Facts

Regulatory Classification

Identification