SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
FDA 510(k) clearance K041017 · decided 2004-06-25
Clearance details
- K-number
- K041017
- Device name
- SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
- Applicant
- Spsmedical Supply Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-04-20
- Decision date
- 2004-06-25
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rush, NY, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.