Cardinal Health Non-Reinforced Surgical Gown
FDA 510(k) clearance K170762 · decided 2017-06-09
Clearance details
- K-number
- K170762
- Device name
- Cardinal Health Non-Reinforced Surgical Gown
- Applicant
- Cardinal Health200, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-03-13
- Decision date
- 2017-06-09
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Waukegan, IL, US
- Third-party review
- No
- Expedited review
- No
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