HAND PACK
FDA 510(k) clearance K914934 · decided 1993-01-21
Clearance details
- K-number
- K914934
- Device name
- HAND PACK
- Applicant
- Westmark Hospital Supplies
- Decision
- Unknown
- Date received
- 1991-11-04
- Decision date
- 1993-01-21
- Days to decision
- 444 days
- Clearance type
- Traditional
- Product code
- KDO
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Grand Rapids, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.