510(k) K922083
K922083 is an FDA 510(k) premarket notification submitted by Research Medical, Inc. for the device "RMI SURGICCAL SITE VISUALIZATION WAND". The FDA issued a decision of Substantially Equivalent on January 29, 1993. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Research Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1993
- Date Received
- May 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lavage, Jet
- Device Class
- Class II
- Regulation Number
- 880.5475
- Review Panel
- HO
- Submission Type