510(k) K931137
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1993
- Date Received
- March 5, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Syringe, Air And/Or Water
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type