510(k) K801554
K801554 is an FDA 510(k) premarket notification submitted by Medi-Spec for the device "STERILE CAST PADDING". The FDA issued a decision of Substantially Equivalent on Aug 4, 1980. The device falls under product code HIX (Maxwell Spot, Ac-Powered), a Class I device regulated under 21 CFR 886.1435. Medi-Spec has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 1980
- Date Received
- Jul 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Maxwell Spot, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1435
- Review Panel
- OP
- Submission Type
- 510(k) Exempt