510(k) K905003
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 28, 1990
- Date Received
- November 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bedding, Disposable, Medical
- Device Class
- Class I
- Regulation Number
- 880.6060
- Review Panel
- HO
- Submission Type