510(k) K790554
K790554 is an FDA 510(k) premarket notification submitted by Exeter Medical Labs, Inc. for the device "EXETER LIP SEAL". The FDA issued a decision of Substantially Equivalent on April 10, 1979. The device falls under product code LFA (Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)), a Class U device. Exeter Medical Labs, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1979
- Date Received
- March 19, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type