Peregrine Wet Set, Model PD400.00
FDA 510(k) K990518 · Peregrine Surgical , Ltd.
510(k) numberK990518
Submission
- Device name
- Peregrine Wet Set, Model PD400.00
- Applicant
- Peregrine Surgical , Ltd.
Doylestown, PA, US - Received
- February 18, 1999
- Decision date
- March 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Peregrine Wet Set, Model PD400.00 cleared by the FDA?
Peregrine Wet Set, Model PD400.00 (K990518) received a 510(k) decision of Substantially Equivalent on March 25, 1999, 35 days after the submission was received.
What is the product code of K990518?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.