FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OSTO-PURE
K Number: K871738
·
Decision Aug 12, 1987
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
101
Applicant Total
1
Review Days
99
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Basic Information
- Device Name
- OSTO-PURE
- K Number
- K871738
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Clearchem Corp.
- Date Received
- May 5, 1987
- Decision Date
- August 12, 1987
- Product Code
- EXB
- 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 |
|---|---|---|---|
| EXB | Collector, Ostomy | FDA class 1 | Gastroenterology, Urology |
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