CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
FDA 510(k) clearance K903545 · decided 1990-11-13
Clearance details
- K-number
- K903545
- Device name
- CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS
- Applicant
- J.J. Skinner, Inc.
- Decision
- Unknown
- Date received
- 1990-08-06
- Decision date
- 1990-11-13
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.