Question 1

Who is the manufacturer of HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K?

Accepted Answer

Hgm, Inc. filed the 510(k) submission for HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K (K850572).

Question 2

What is the FDA product code for HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K?

Accepted Answer

HQF. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

Question 3

When was HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K cleared by the FDA?

Accepted Answer

Apr 23, 1985 (decision: SESE).

Question 4

What is the regulatory pathway for HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K?

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	K850572
Device Name	HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K
Applicant	Hgm, Inc.
Product Code	HQF · Ophthalmic
Decision Date	Apr 23, 1985
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4390
Device Class	Class 2

HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K

Device Facts

Regulatory Classification

Identification