Rmi Surgiccal Site Visualization Wand
FDA 510(k) K922083 · Research Medical, Inc.
510(k) numberK922083
Submission
- Device name
- Rmi Surgiccal Site Visualization Wand
- Applicant
- Research Medical, Inc.
Midvale, UT, US - Received
- May 4, 1992
- Decision date
- January 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Rmi Surgiccal Site Visualization Wand cleared by the FDA?
Rmi Surgiccal Site Visualization Wand (K922083) received a 510(k) decision of Substantially Equivalent on January 29, 1993, 270 days after the submission was received.
What is the product code of K922083?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.