510(k) K932128
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1994
- Date Received
- May 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Bulbs, Miscellaneous, For Endoscope
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type