FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLADDER RETENTION CATHETERIZATION TRAY
K Number: K791674
·
Decision Nov 5, 1979
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
14
Review Days
70
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Basic Information
- Device Name
- BLADDER RETENTION CATHETERIZATION TRAY
- K Number
- K791674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Latex Ind., Inc.
- Date Received
- August 27, 1979
- Decision Date
- November 5, 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 Latex Ind., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812058 | AKRON URINARY DRAINAGE BAT | Jul 31, 1981 | Substantially Equivalent |
| K810281 | UROLOGICAL CATHETERS | Feb 25, 1981 | Substantially Equivalent |
| K781751 | CATHETER, AKRON FOLEY TEFLON | Jan 22, 1979 | Substantially Equivalent |
| K781433 | AKRON MALE EXTERNAL CATHETER | Nov 3, 1978 | Substantially Equivalent |
| K772277 | BLADDER RETENTION-CATHETHERIZATIONTRAY | Mar 2, 1978 | Substantially Equivalent |
| K780267 | CATH TRAY W/OUT CATHETER | Feb 24, 1978 | Substantially Equivalent |
| K772342 | ROBINSON KIT - 750014 & 750016 | Feb 24, 1978 | Substantially Equivalent |
| K772340 | CATHETERIZATION KIT 732016-732018 | Feb 24, 1978 | Substantially Equivalent |
| K780268 | BLADDER CATH KIT W/OUT CATHETER | Feb 24, 1978 | Substantially Equivalent |
| K772341 | BLADDER KIT - 734000 | Feb 24, 1978 | Substantially Equivalent |