Question 1

Who is the manufacturer of MEDI PUMP ASPIRATOR MODELS 1130 AND 1135?

Accepted Answer

Thomas Industries filed the 510(k) submission for MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 (K952806).

Question 2

What is the FDA product code for MEDI PUMP ASPIRATOR MODELS 1130 AND 1135?

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 MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 cleared by the FDA?

Accepted Answer

Oct 26, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for MEDI PUMP ASPIRATOR MODELS 1130 AND 1135?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like MEDI PUMP ASPIRATOR MODELS 1130 AND 1135?

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	K952806
Device Name	MEDI PUMP ASPIRATOR MODELS 1130 AND 1135
Applicant	Thomas Industries
Product Code	BTA · General, Plastic Surgery
Decision Date	Oct 26, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2

MEDI PUMP ASPIRATOR MODELS 1130 AND 1135

Device Facts

Regulatory Classification

Identification