510(k) K972923
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1997
- Date Received
- August 8, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Hearing (Insert)
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type