FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
K Number: K163586
·
Decision Mar 17, 2017
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
49
Applicant Total
1
Review Days
87
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Basic Information
- Device Name
- Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
- K Number
- K163586
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trovrx, Inc. Dba Trovita Health Science
- Date Received
- December 20, 2016
- Decision Date
- March 17, 2017
- Product Code
- PIF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | FDA class 2 | Gastroenterology, Urology |
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