Question 1

Who is the manufacturer of TOTE-L-VAC?

Accepted Answer

Aeros Instruments, Inc. filed the 510(k) submission for TOTE-L-VAC (K932051).

Question 2

What is the FDA product code for TOTE-L-VAC?

Accepted Answer

BTA. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

Question 3

When was TOTE-L-VAC cleared by the FDA?

Accepted Answer

Nov 12, 1993 (decision: SESE).

Question 4

What is the regulatory pathway for TOTE-L-VAC?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TOTE-L-VAC?

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	K932051
Device Name	TOTE-L-VAC
Applicant	Aeros Instruments, Inc.
Product Code	BTA · General, Plastic Surgery
Decision Date	Nov 12, 1993
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2

TOTE-L-VAC

Device Facts

Regulatory Classification

Identification