REFLECTIVE BLANKET— 510(k) K860066
Substantially EquivalentO.R. Concepts, Inc.
FDA 510(k) clearance K860066 for REFLECTIVE BLANKET, Substantially Equivalent on 1986-02-19. Applicant: O.R. Concepts, Inc.. Device class: 1.
Clearance details
- Applicant
- O.R. Concepts, Inc.
- Product code
- Code KME
- Device class
- Class 1
- Regulation
- 21 CFR 880.6060
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code KME
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