FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENEMA SET
K Number: K771792
·
Decision Oct 20, 1977
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
29
Applicant Total
10
Review Days
28
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Basic Information
- Device Name
- ENEMA SET
- K Number
- K771792
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5210
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Chase Mfg. Co.
- Date Received
- September 22, 1977
- Decision Date
- October 20, 1977
- 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 Chase Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K791513 | ADAMCO DUST COVER | Oct 11, 1979 | Substantially Equivalent |
| K790993 | INSTANT HOT & COLD PACKS | Sep 7, 1979 | Substantially Equivalent |
| K790644 | SUBMAX | Apr 26, 1979 | Substantially Equivalent |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Feb 21, 1978 | Substantially Equivalent |
| K771791 | NEEDLE COUNTING | Oct 4, 1977 | Substantially Equivalent |
| K770900 | CAST BRWM, FRACTURE | Jul 21, 1977 | Substantially Equivalent |
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | Jul 21, 1977 | Substantially Equivalent |
| K770899 | FRACTURE CAST BRACE, POLY | Jul 21, 1977 | Substantially Equivalent |
| K770173 | STOCKINETTE | Feb 8, 1977 | Substantially Equivalent |