510(k) K924196
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 1993
- Date Received
- August 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Needle, Gastroenterologic
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type