510(k) K823820
K823820 is an FDA 510(k) premarket notification submitted by Danek Medical, Inc. for the device "ABDUCTION PILLOW". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code IOZ (Splint, Abduction, Congenital Hip Dislocation), a Class I device regulated under 21 CFR 890.3665. Danek Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1983
- Date Received
- December 17, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Abduction, Congenital Hip Dislocation
- Device Class
- Class I
- Regulation Number
- 890.3665
- Review Panel
- PM
- Submission Type