CONVERTORS SMS POLYOLEFIN GOWN
FDA 510(k) clearance K020593 · decided 2002-03-18
Clearance details
- K-number
- K020593
- Device name
- CONVERTORS SMS POLYOLEFIN GOWN
- Applicant
- Allegiance Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-22
- Decision date
- 2002-03-18
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
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