Question 1

Who is the manufacturer of PAD, PETROLATUM & BISMUTH  TRIBROMOPHENATE IMPREG.?

Accepted Answer

Steridyne Laboratories, Inc. filed the 510(k) submission for PAD, PETROLATUM & BISMUTH  TRIBROMOPHENATE IMPREG. (K870430).

Question 2

What is the FDA product code for PAD, PETROLATUM & BISMUTH  TRIBROMOPHENATE IMPREG.?

Accepted Answer

FRO. as a Class U device in the SU panel.

Question 3

When was PAD, PETROLATUM & BISMUTH  TRIBROMOPHENATE IMPREG. cleared by the FDA?

Accepted Answer

Apr 13, 1987 (decision: SN).

Question 4

What is the regulatory pathway for PAD, PETROLATUM & BISMUTH  TRIBROMOPHENATE IMPREG.?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PAD, PETROLATUM & BISMUTH  TRIBROMOPHENATE IMPREG.?

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	K870430
Device Name	PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.
Applicant	Steridyne Laboratories, Inc.
Product Code	FRO · SU
Decision Date	Apr 13, 1987
Decision	SN
Submission Type	Traditional
Device Class	Class U

PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.

Device Facts