510(k) K945376
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1995
- Date Received
- October 21, 1994
- 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