510(k) K890309
K890309 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "MALIS SURGICAL STOOL". The FDA issued a decision of Substantially Equivalent on Feb 14, 1989. The device falls under product code FZM (Stool, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Valley Forge Scientific Corp. has 26 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 14, 1989
- Date Received
- Jan 23, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Stool, Operating-Room
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type
- 510(k) Exempt