Question 1

Who is the manufacturer of REPLACE-A-TIP ADJUST. LOW TEMP.-?

Accepted Answer

Suncoast Medical Manufacturers, Inc. filed the 510(k) submission for REPLACE-A-TIP ADJUST. LOW TEMP.- (K841459).

Question 2

What is the FDA product code for REPLACE-A-TIP ADJUST. LOW TEMP.-?

Accepted Answer

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was REPLACE-A-TIP ADJUST. LOW TEMP.- cleared by the FDA?

Accepted Answer

Dec 7, 1984 (decision: SESE).

Question 4

What is the regulatory pathway for REPLACE-A-TIP ADJUST. LOW TEMP.-?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like REPLACE-A-TIP ADJUST. LOW TEMP.-?

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	K841459
Device Name	REPLACE-A-TIP ADJUST. LOW TEMP.-
Applicant	Suncoast Medical Manufacturers, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Dec 7, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2

REPLACE-A-TIP ADJUST. LOW TEMP.-

Device Facts

Regulatory Classification

Identification