FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUCK-TITE COLON FLUID RETAINER
K Number: K833860
·
Decision Dec 27, 1983
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
29
Applicant Total
2
Review Days
50
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Basic Information
- Device Name
- TUCK-TITE COLON FLUID RETAINER
- K Number
- K833860
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5210
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Clayton Medical Products, Inc.
- Date Received
- November 7, 1983
- Decision Date
- December 27, 1983
- Product Code
- FCE
- 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 |
|---|---|---|---|
| FCE | Enema Kit | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Clayton Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K790535 | CLAYTON COLON CLEANSING KIT | Jun 7, 1979 | Substantially Equivalent |