510(k) K850016
K850016 is an FDA 510(k) premarket notification submitted by East Texas Lighthouse For the Blind for the device "TOWEL PACK, SURGICAL". The FDA issued a decision of Substantially Equivalent on January 23, 1985. East Texas Lighthouse For the Blind has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1985
- Date Received
- January 2, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No