510(k) K951104
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1995
- Date Received
- March 10, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscopic Storage Cover
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To protect delicate parts of the endoscope during transport and storage. May also be used to protect during sterilization.