DIB INFUSOR
FDA 510(k) clearance K955849 · decided 1996-08-05
Clearance details
- K-number
- K955849
- Device name
- DIB INFUSOR
- Applicant
- Novacon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-27
- Decision date
- 1996-08-05
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St.Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.