510(k) K830852
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1983
- Date Received
- March 17, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Hygiene
- Device Class
- Class I
- Regulation Number
- 890.5050
- Review Panel
- PM
- Submission Type