510(k) K790195
K790195 is an FDA 510(k) premarket notification submitted by American Safety for the device "FOOT VALVE". The FDA issued a decision of Substantially Equivalent on February 26, 1979. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. American Safety has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1979
- Date Received
- January 24, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Surgical Instrument, Pneumatic Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type