510(k) K832318
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1983
- Date Received
- July 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Intestine
- Device Class
- Class I
- Regulation Number
- 878.4100
- Review Panel
- SU
- Submission Type