510(k) K803239
K803239 is an FDA 510(k) premarket notification submitted by Danek Medical, Inc. for the device "SOFTGOOD PRODUCTS AND SPLINTS". The FDA issued a decision of Substantially Equivalent on January 9, 1981. The device falls under product code IPX (Orthosis, Rib Fracture, Soft), a Class I device regulated under 21 CFR 890.3490. Danek Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1981
- Date Received
- December 23, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Rib Fracture, Soft
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type