510(k) K843049
K843049 is an FDA 510(k) premarket notification submitted by Penn-Med Technology, Inc. for the device "CURING LIGHT". The FDA issued a decision of Substantially Equivalent on April 12, 1985. Penn-Med Technology, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1985
- Date Received
- August 3, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No