20G x 5/8 Pro-Lock CT Safety Infusion Set
FDA 510(k) clearance K171333 · decided 2017-07-18
Clearance details
- K-number
- K171333
- Device name
- 20G x 5/8 Pro-Lock CT Safety Infusion Set
- Applicant
- Medcomp (Dba Medical Components, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2017-05-08
- Decision date
- 2017-07-18
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- PTI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.