TERUMO SURGUARD 2 SAFETY NEEDLE
FDA 510(k) clearance K031453 · decided 2003-07-08
Clearance details
- K-number
- K031453
- Device name
- TERUMO SURGUARD 2 SAFETY NEEDLE
- Applicant
- Terumo Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-07
- Decision date
- 2003-07-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.