Question 1

Who is the manufacturer of KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML?

Accepted Answer

Kendall Healthcare Products Co. Div.Of Tyco Health filed the 510(k) submission for KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML (K925749).

Question 2

What is the FDA product code for KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML?

Accepted Answer

GCY. It is classified under 21 CFR 878.4680 as a Class 1 device in the General, Plastic Surgery panel.

Question 3

When was KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML cleared by the FDA?

Accepted Answer

Feb 1, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML?

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	K925749
Device Name	KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML
Applicant	Kendall Healthcare Products Co. Div.Of Tyco Health
Product Code	GCY · General, Plastic Surgery
Decision Date	Feb 1, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4680
Device Class	Class 1

KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML

Device Facts

Regulatory Classification

Identification