510(k) K940132
K940132 is an FDA 510(k) premarket notification submitted by Crown Delta Corp. for the device "PODIATRIC MATERIAL". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code MNE (Orthosis, Moldable, Supportive, Skin Protective), a Class I device regulated under 21 CFR 890.3475. Crown Delta Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1994
- Date Received
- January 3, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Moldable, Supportive, Skin Protective
- Device Class
- Class I
- Regulation Number
- 890.3475
- Review Panel
- PM
- Submission Type