510(k) K811688
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1981
- Date Received
- June 15, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Syringe, Lead
- Device Class
- Class I
- Regulation Number
- 892.6500
- Review Panel
- RA
- Submission Type