FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYGON PAC-MONITORING LINES & FLUID ADMIN
K Number: K770707
·
Decision Jun 3, 1977
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
88
Applicant Total
39
Review Days
46
Basic Information
- Device Name
- TYGON PAC-MONITORING LINES & FLUID ADMIN
- K Number
- K770707
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- NORTON PERFORMANCE PLASTICS CORP.
- Date Received
- April 18, 1977
- Decision Date
- June 3, 1977
- Product Code
- FMG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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