BEBIG PLAQUES RUM101-RUM114
FDA 510(k) clearance K931393 · decided 1994-03-16
Clearance details
- K-number
- K931393
- Device name
- BEBIG PLAQUES RUM101-RUM114
- Applicant
- Bebig, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-19
- Decision date
- 1994-03-16
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- KXK
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.