Question 1

Who is the manufacturer of SPECTRUM DESIGNS SPECTRAGEL?

Accepted Answer

Spectrum Designs, Inc. filed the 510(k) submission for SPECTRUM DESIGNS SPECTRAGEL (K970702).

Question 2

What is the FDA product code for SPECTRUM DESIGNS SPECTRAGEL?

Accepted Answer

MDA. It is classified under 21 CFR 878.4025 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was SPECTRUM DESIGNS SPECTRAGEL cleared by the FDA?

Accepted Answer

May 12, 1997 (decision: SESE).

Question 4

What is the regulatory pathway for SPECTRUM DESIGNS SPECTRAGEL?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like SPECTRUM DESIGNS SPECTRAGEL?

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	K970702
Device Name	SPECTRUM DESIGNS SPECTRAGEL
Applicant	Spectrum Designs, Inc.
Product Code	MDA · General, Plastic Surgery
Decision Date	May 12, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4025
Device Class	Class 1

SPECTRUM DESIGNS SPECTRAGEL

Device Facts

Regulatory Classification

Identification