510(k) K933742
K933742 is an FDA 510(k) premarket notification submitted by Bio-Medical Devices, Inc. for the device "TOP GUN". The FDA issued a decision of Substantially Equivalent on April 7, 1994. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Bio-Medical Devices, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1994
- Date Received
- August 3, 1993
- 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