Question 1

Who is the manufacturer of ULTRA-VIOLET GOGGLETS?

Accepted Answer

Health Saver Products filed the 510(k) submission for ULTRA-VIOLET GOGGLETS (K861333).

Question 2

When was ULTRA-VIOLET GOGGLETS cleared by the FDA?

Accepted Answer

Apr 28, 1986 (decision: SESE).

Question 3

What is the regulatory pathway for ULTRA-VIOLET GOGGLETS?

Accepted Answer

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

Question 4

Who can help prepare an FDA 510(k) submission like ULTRA-VIOLET GOGGLETS?

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	K861333
Device Name	ULTRA-VIOLET GOGGLETS
Applicant	Health Saver Products
Decision Date	Apr 28, 1986
Decision	SESE
Submission Type	Traditional

ULTRA-VIOLET GOGGLETS

Device Facts