510(k) K781907
K781907 is an FDA 510(k) premarket notification submitted by Crown Delta Corp. for the device "EAR STOPPLES FOR NOISE ATTENTION". The FDA issued a decision of Substantially Equivalent on November 22, 1978. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Crown Delta Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1978
- Date Received
- November 14, 1978
- 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