510(k) K781491
K781491 is an FDA 510(k) premarket notification submitted by Mcghan Medical Corp. for the device "PRO-MOLD, CUSTOM EAR". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Mcghan Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1978
- Date Received
- August 28, 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