510(k) K850945
K850945 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "HUNTLEIGH FLOWTRON AIR HAND GARMENT, HG300". The FDA issued a decision of Substantially Equivalent on August 20, 1985. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1985
- Date Received
- March 7, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No