BARRIER SURGICAL GOWNS
FDA 510(k) clearance K050786 · decided 2005-05-09
Clearance details
- K-number
- K050786
- Device name
- BARRIER SURGICAL GOWNS
- Applicant
- Molnlycke Health Care
- Decision
- Substantially Equivalent
- Date received
- 2005-03-28
- Decision date
- 2005-05-09
- Days to decision
- 42 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
- Newton, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.