510(k) K861343
K861343 is an FDA 510(k) premarket notification submitted by Tri W-G, Inc. for the device "R1618, R1619 & R1654 ICE MAKING MACHINES". The FDA issued a decision of Substantially Equivalent on July 17, 1986. Tri W-G, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1986
- Date Received
- April 7, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No