NON-KOR ACCESS KITS
FDA 510(k) clearance K852831 · decided 1985-09-19
Clearance details
- K-number
- K852831
- Device name
- NON-KOR ACCESS KITS
- Applicant
- Creative Care Systems, Inc.
- Decision
- Unknown
- Date received
- 1985-07-02
- Decision date
- 1985-09-19
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Maplewood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.