FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE EXTENSION TUBES INDIV. PKG.
K Number: K792128
·
Decision Jan 16, 1980
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
12
Review Days
84
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Basic Information
- Device Name
- STERILE EXTENSION TUBES INDIV. PKG.
- K Number
- K792128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Tronomed, Inc.
- Date Received
- October 24, 1979
- Decision Date
- January 16, 1980
- 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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FDA 510(k)
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Other Clearances by Tronomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952659 | TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM | Jan 11, 1996 | Substantially Equivalent |
| K853303 | LIFELINC LEADWIRE | Sep 18, 1985 | Substantially Equivalent |
| K853452 | LIFE LINC PATIENT CABLE | Sep 10, 1985 | Substantially Equivalent |
| K841092 | HIGH PRESSURE FLEX. CONNECTING TUBING | Jul 24, 1985 | Substantially Equivalent |
| K792125 | 3&4 WAY PLASTIC STOPCOCKS, NONSTERILE | Jan 16, 1980 | Substantially Equivalent |
| K792124 | TANDEM ASSEMBLED 3&4 WAY STOPCOCKS | Jan 16, 1980 | Substantially Equivalent |
| K792126 | 3&4 WAY PLASTIC STERILE STPCKS. PKG. | Jan 16, 1980 | Substantially Equivalent |
| K792127 | PLAS. STCK. W/EXTENSION TUBE/STERILE | Jan 16, 1980 | Substantially Equivalent |
| K771645 | ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE | Oct 18, 1977 | Substantially Equivalent |
| K771027 | ELECTROCARDIOGRAPHIC PATIENT CABLES | Jul 5, 1977 | Substantially Equivalent |