AMD Ritmed AssureWear VersaGown— 510(k) K190306
Substantially EquivalentAmd Medicom, Inc.
FDA 510(k) clearance K190306 for AMD Ritmed AssureWear VersaGown, Substantially Equivalent on 2020-01-17. Applicant: Amd Medicom, Inc.. Device class: 2.
Clearance details
- Applicant
- Amd Medicom, Inc.
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pointe-Claire, Montreal, CA
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