Powered Vacuum Aspirator 1110-G-030

FDA 510(k) K920287 · Stirn Industries

Substantially Equivalent

510(k) numberK920287

Submission

Device name
Powered Vacuum Aspirator 1110-G-030
Applicant
Stirn Industries
Dayton, NJ, US
Received
January 22, 1992
Decision date
June 29, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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K182950Acare Suction UnitJCX · Traditional Acare Technology Co., Ltd.08/23/2019SE
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More from Taiwan Biomaterial Co., Ltd.

510(k)DeviceDecision
K920288Powered Vacuum Aspirator 1110-G-062JCX · Traditional 06/29/1992SE
K911206MAXIMA-10FLE · Traditional 11/29/1991SE

Questions and answers

When was Powered Vacuum Aspirator 1110-G-030 cleared by the FDA?

Powered Vacuum Aspirator 1110-G-030 (K920287) received a 510(k) decision of Substantially Equivalent on June 29, 1992, 159 days after the submission was received.

What is the product code of K920287?

The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.