UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE
FDA 510(k) clearance K860168 · decided 1986-02-19
Clearance details
- K-number
- K860168
- Device name
- UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE
- Applicant
- Universal Medical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-17
- Decision date
- 1986-02-19
- Days to decision
- 33 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Ballston Spa, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.