510(k) K842304
K842304 is an FDA 510(k) premarket notification submitted by Hydro-Med Products, Inc. for the device "THE PATHFINDER". The FDA issued a decision of Substantially Equivalent on August 1, 1984. Hydro-Med Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1984
- Date Received
- June 11, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No