510(k) K001003
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2001
- Date Received
- March 29, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Mattress (Medical Purposes)
- Device Class
- Class I
- Regulation Number
- 880.6190
- Review Panel
- HO
- Submission Type