Question 1

Who is the manufacturer of PORTABLE ASPIRATOR?

Accepted Answer

Sam Say Assoc. filed the 510(k) submission for PORTABLE ASPIRATOR (K791210).

Question 2

What is the FDA product code for PORTABLE ASPIRATOR?

Accepted Answer

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

Question 3

When was PORTABLE ASPIRATOR cleared by the FDA?

Accepted Answer

Jul 24, 1979 (decision: SESE).

Question 4

What is the regulatory pathway for PORTABLE ASPIRATOR?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like PORTABLE ASPIRATOR?

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	K791210
Device Name	PORTABLE ASPIRATOR
Applicant	Sam Say Assoc.
Product Code	JCX · General, Plastic Surgery
Decision Date	Jul 24, 1979
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2

PORTABLE ASPIRATOR

Device Facts

Regulatory Classification

Identification