FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NELATON CATHETER
K Number: K792038
·
Decision Nov 13, 1979
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
236
Applicant Total
56
Review Days
32
Basic Information
- Device Name
- NELATON CATHETER
- K Number
- K792038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- AMERICAN HOSPITAL SUPPLY CORP.
- Date Received
- October 12, 1979
- Decision Date
- November 13, 1979
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by AMERICAN HOSPITAL SUPPLY CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K854739 | AMERICAN STERILE SURGICAL ABSORBENT TOWEL | Dec 27, 1985 | Substantially Equivalent |
| K854759 | AMERICAN STERILE MAYO STAND TRAY | Dec 17, 1985 | Substantially Equivalent |
| K832826 | AAP DOSIMETRY RELEASE OR BASIN SETS | Apr 23, 1984 | Substantially Equivalent |
| K830546 | DOSIMETRIC RELEASE | May 25, 1983 | Substantially Equivalent |
| K822990 | CONVERTORS PRIMARY WOUND DRESSING II | Apr 12, 1983 | Substantially Equivalent |
| K830343 | CONTAINER W/PRIMING SOLUTION | Mar 17, 1983 | Substantially Equivalent |
| K830301 | STRATUS FLUOROMETRIC ENZYME IMMUN0- | Feb 25, 1983 | Substantially Equivalent |
| K822755 | LATEX PENROSE TUBING | Jan 21, 1983 | Substantially Equivalent |
| K823418 | HEYER-SCHUTE UNIVERSAL URETERAL STENT | Dec 3, 1982 | Substantially Equivalent |
| K822966 | CONVERTORS DISPOSABLE DRESSING SPONGE | Nov 5, 1982 | Substantially Equivalent |