Question 1

Who is the manufacturer of DERMAGRAN HYDROPHILIC OINTMENT?

Accepted Answer

Derma Sciences, Inc. filed the 510(k) submission for DERMAGRAN HYDROPHILIC OINTMENT (K963603).

Question 2

What is the FDA product code for DERMAGRAN HYDROPHILIC OINTMENT?

Accepted Answer

KMF. It is classified under 21 CFR 880.5090 as a Class 1 device in the General Hospital panel.

Question 3

When was DERMAGRAN HYDROPHILIC OINTMENT cleared by the FDA?

Accepted Answer

Nov 27, 1996 (decision: SN).

Question 4

What is the regulatory pathway for DERMAGRAN HYDROPHILIC OINTMENT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like DERMAGRAN HYDROPHILIC OINTMENT?

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	K963603
Device Name	DERMAGRAN HYDROPHILIC OINTMENT
Applicant	Derma Sciences, Inc.
Product Code	KMF · General Hospital
Decision Date	Nov 27, 1996
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 880.5090
Device Class	Class 1

DERMAGRAN HYDROPHILIC OINTMENT

Device Facts

Regulatory Classification

Identification