510(k) K781363
K781363 is an FDA 510(k) premarket notification submitted by Cutler Biomedical for the device "CAST SHOE". The FDA issued a decision of Substantially Equivalent on August 14, 1978. 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
- August 14, 1978
- Date Received
- August 7, 1978
- 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