510(k) K833450
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 1983
- Date Received
- October 5, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shield, Nipple
- Device Class
- Class I
- Regulation Number
- 880.5630
- Review Panel
- HO
- Submission Type