S-Scort...Jr Quickdraw, Model 2400

FDA 510(k) K041154 · Sscor

Substantially Equivalent

510(k) numberK041154

Submission

Device name
S-Scort...Jr Quickdraw, Model 2400
Applicant
Sscor
Sun Valley, CA, US
Received
May 3, 2004
Decision date
May 18, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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More from Shenzhen Kingboom Technology Co., Ltd.

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K950464Sscor/Board ..3 Model 23000 Pre-Assembled Suction System for Patient Transport VehiclesGCX · Traditional 04/25/1995SE
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Questions and answers

When was S-Scort...Jr Quickdraw, Model 2400 cleared by the FDA?

S-Scort...Jr Quickdraw, Model 2400 (K041154) received a 510(k) decision of Substantially Equivalent on May 18, 2004, 15 days after the submission was received.

What is the product code of K041154?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.