510(k) K101593— EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
Substantially EquivalentExact Medical Manufacturing, Inc.
Clearance details
- Applicant
- Exact Medical Manufacturing, Inc.
- Product code
- Code FYA
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.