PEDI-SPIDER STRAP
FDA 510(k) clearance K061721 · decided 2006-08-17
Clearance details
- K-number
- K061721
- Device name
- PEDI-SPIDER STRAP
- Applicant
- Emergency Products and Research
- Decision
- Substantially Equivalent
- Date received
- 2006-06-19
- Decision date
- 2006-08-17
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- NZD
- Device class
- 1
- Regulation number
- 880.6900
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kent, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.