HOBBS MEDICAL MICROBIOLOGY BRUSH
FDA 510(k) clearance K893729 · decided 1989-08-28
Clearance details
- K-number
- K893729
- Device name
- HOBBS MEDICAL MICROBIOLOGY BRUSH
- Applicant
- Hobbs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-17
- Decision date
- 1989-08-28
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- FDX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stafford Springs, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bronchial Microbiology Brush, Catalog Number 4310 and 4320. Microbial sampling is performe recall (Z-0711-2022) | Hobbs Medical, Inc. | 2022-03-02 |