DISPOSABLE SYRINGES & NEEDLES
FDA 510(k) clearance K854563 · decided 1985-12-09
Clearance details
- K-number
- K854563
- Device name
- DISPOSABLE SYRINGES & NEEDLES
- Applicant
- Medelec Intl. Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-14
- Decision date
- 1985-12-09
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Miami Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.