Anspach Irrigation Pump and Irrigation Pump II
FDA 510(k) K030576 · The Anspach Effort, Inc.
510(k) numberK030576
Submission
- Device name
- Anspach Irrigation Pump and Irrigation Pump II
- Applicant
- The Anspach Effort, Inc.
Palm Beach Gardens, FL, US - Received
- February 24, 2003
- Decision date
- May 21, 2003
- 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 Anspach Irrigation Pump and Irrigation Pump II cleared by the FDA?
Anspach Irrigation Pump and Irrigation Pump II (K030576) received a 510(k) decision of Substantially Equivalent on May 21, 2003, 86 days after the submission was received.
What is the product code of K030576?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.