SPECIMEN CONTAINER
FDA 510(k) clearance K896794 · decided 1990-03-01
Clearance details
- K-number
- K896794
- Device name
- SPECIMEN CONTAINER
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
- Decision
- Substantially Equivalent
- Date received
- 1989-12-01
- Decision date
- 1990-03-01
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LIO
- Device class
- 1
- Regulation number
- 866.2900
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.