BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE)
FDA 510(k) clearance K950898 · decided 1995-08-24
Clearance details
- K-number
- K950898
- Device name
- BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE)
- Applicant
- Biosystems
- Decision
- Substantially Equivalent
- Date received
- 1995-02-27
- Decision date
- 1995-08-24
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- MMK
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Farmingdale, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.