510(k) K790322
K790322 is an FDA 510(k) premarket notification submitted by Applied Medical Research for the device "OPTIONAL ACCESSORY FOOT SWITCH MODEL 100". The FDA issued a decision of Substantially Equivalent on May 14, 1979. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Applied Medical Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1979
- Date Received
- February 15, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type