COMET COSMIC 203/218
FDA 510(k) clearance K861527 · decided 1986-07-31
Clearance details
- K-number
- K861527
- Device name
- COMET COSMIC 203/218
- Applicant
- Fuyo U.S.A. Co., Ltd.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1986-04-24
- Decision date
- 1986-07-31
- Days to decision
- 98 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Bellevue, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.