Simpulse Solo Suction Irrigator
FDA 510(k) K942886 · Davol Inc., Sub. C. R. Bard, Inc.
510(k) numberK942886
Submission
- Device name
- Simpulse Solo Suction Irrigator
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
Canston, RI, US - Received
- June 17, 1994
- Decision date
- July 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
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Questions and answers
When was Simpulse Solo Suction Irrigator cleared by the FDA?
Simpulse Solo Suction Irrigator (K942886) received a 510(k) decision of Substantially Equivalent on July 19, 1994, 32 days after the submission was received.
What is the product code of K942886?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.