510(k) K811157
K811157 is an FDA 510(k) premarket notification submitted by Dyn-A-Med Products for the device "BLADE, TONGUE". The FDA issued a decision of Substantially Equivalent on May 27, 1981. Dyn-A-Med Products has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1981
- Date Received
- April 28, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No