SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
FDA 510(k) clearance K022099 · decided 2002-09-20
Clearance details
- K-number
- K022099
- Device name
- SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
- Applicant
- Hdc Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-27
- Decision date
- 2002-09-20
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.