Personal Infusor with Drug Disposal Septal Port

FDA 510(k) K990208 · Science Incorporated

Substantially Equivalent

510(k) numberK990208

Submission

Device name
Personal Infusor with Drug Disposal Septal Port
Applicant
Science Incorporated
Bloomington, MN, US
Received
January 21, 1999
Decision date
March 25, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MEG – Syringe, Antistick
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5860
Specialty
General Hospital

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More from Jiangsu Kangbao Medical Equipment Co., Ltd.

510(k)DeviceDecision
K020881Modification to Personal Infusor Local Pain Management Procedural KitFRN · Special 03/27/2002SE
K010824Personal Infusor Local Pain Management Procedural KitMEB · Traditional 06/05/2001SE
K971362Personal InfusorMEB · Traditional 12/04/1997SE

Questions and answers

When was Personal Infusor with Drug Disposal Septal Port cleared by the FDA?

Personal Infusor with Drug Disposal Septal Port (K990208) received a 510(k) decision of Substantially Equivalent on March 25, 1999, 63 days after the submission was received.

What is the product code of K990208?

The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.