510(k) K820140
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1982
- Date Received
- January 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Cast
- Device Class
- Class I
- Regulation Number
- 890.3025
- Review Panel
- PM
- Submission Type