510(k) K954972
K954972 is an FDA 510(k) premarket notification submitted by Venture Management Corp. for the device "LYELL SOUND". The FDA issued a decision of Substantially Equivalent on January 24, 1996. The device falls under product code FBS (Sound, Metal, Interconnected), a Class I device regulated under 21 CFR 876.4590. Venture Management Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1996
- Date Received
- October 27, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sound, Metal, Interconnected
- Device Class
- Class I
- Regulation Number
- 876.4590
- Review Panel
- GU
- Submission Type