510(k) K926337
K926337 is an FDA 510(k) premarket notification submitted by Innovative Surgical Devices Corp. for the device "BONE LAVAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 11, 1993. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Innovative Surgical Devices Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 1993
- Date Received
- December 17, 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