510(k) K801743
K801743 is an FDA 510(k) premarket notification submitted by Alimed, Inc. for the device "PLASTAZOTE SHOE". The FDA issued a decision of Substantially Equivalent on August 7, 1980. The device falls under product code KNP (Orthosis, Corrective Shoe), a Class I device regulated under 21 CFR 890.3475. Alimed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1980
- Date Received
- July 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Corrective Shoe
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type