Question 1

Who is the manufacturer of FLOWERS NASAL IMPLANT?

Accepted Answer

Implantech Associates, Inc. filed the 510(k) submission for FLOWERS NASAL IMPLANT (K904656).

Question 2

What is the FDA product code for FLOWERS NASAL IMPLANT?

Accepted Answer

FZE. It is classified under 21 CFR 878.3680 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was FLOWERS NASAL IMPLANT cleared by the FDA?

Accepted Answer

Dec 18, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for FLOWERS NASAL IMPLANT?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like FLOWERS NASAL IMPLANT?

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	K904656
Device Name	FLOWERS NASAL IMPLANT
Applicant	Implantech Associates, Inc.
Product Code	FZE · General, Plastic Surgery
Decision Date	Dec 18, 1990
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3680
Device Class	Class 2

FLOWERS NASAL IMPLANT

Device Facts

Regulatory Classification

Identification