FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYGON M-60/TYGON M-70
K Number: K770299
·
Decision Mar 16, 1977
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
39
Review Days
30
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Basic Information
- Device Name
- TYGON M-60/TYGON M-70
- K Number
- K770299
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Norton Performance Plastics Corp.
- Date Received
- February 14, 1977
- Decision Date
- March 16, 1977
- Product Code
- FID
- 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 |
|---|---|---|---|
| FID | Tubing, Dialysate | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FID), ordered by most recent decision date.
TUBING, DIALYSATE (AND CONNECTOR)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Norton Performance Plastics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K853791 | NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 | Dec 9, 1985 | Substantially Equivalent |
| K852914 | ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION | Sep 25, 1985 | Substantially Equivalent |
| K851299 | CORRECT FLO | May 7, 1985 | Substantially Equivalent |
| K842858 | FLUID ADMINISTRATION LINE W/SPIKE 14-923 | Sep 11, 1984 | Substantially Equivalent |
| K841828 | CENTRAL VENOUS CATHETER W/BIG-GARD | Jul 13, 1984 | Substantially Equivalent |
| K840240 | MICROFUSE INTRAVENOUS CATHETER SET | Apr 17, 1984 | Substantially Equivalent |
| K831587 | TEMP. REPAIR KIT-DUAL LUMEN CATHETER | Oct 19, 1983 | Substantially Equivalent |
| K831698 | DISPOSABLE PRESSURE TRANSDUCER#14004195 | Aug 11, 1983 | Substantially Equivalent |
| K830788 | CENTRAL VEIN CATHERIZATION KIT-14-690- | Apr 30, 1983 | Substantially Equivalent |
| K830813 | FRENCH PERCUTANEOUS SHEATH INTRODUCER | Apr 28, 1983 | Substantially Equivalent |