510(k) K832483
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1984
- Date Received
- July 25, 1983
- 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