510(k) K790652
K790652 is an FDA 510(k) premarket notification submitted by Togard, Inc. for the device "TOGUARD". The FDA issued a decision of Substantially Equivalent on April 4, 1979. The device falls under product code IPG (Shoe, Cast), a Class I device regulated under 21 CFR 890.3025.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1979
- Date Received
- April 4, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoe, Cast
- Device Class
- Class I
- Regulation Number
- 890.3025
- Review Panel
- PM
- Submission Type