R1618, R1619 & R1654 ICE MAKING MACHINES
FDA 510(k) clearance K861343 · decided 1986-07-17
Clearance details
- K-number
- K861343
- Device name
- R1618, R1619 & R1654 ICE MAKING MACHINES
- Applicant
- Tri W-G, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-07
- Decision date
- 1986-07-17
- Days to decision
- 101 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Valley City, ND, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.