FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRO-FLO SYSTEM
K Number: K931896
·
Decision Aug 26, 1993
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
29
Applicant Total
4
Review Days
133
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Basic Information
- Device Name
- PRO-FLO SYSTEM
- K Number
- K931896
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5210
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lafayette Pharmacal, Inc.
- Date Received
- April 15, 1993
- Decision Date
- August 26, 1993
- Product Code
- FCE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- RA
- 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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