FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KODNER ANAL PERIONEAL RETRACTOR
K Number: K870897
·
Decision Jun 4, 1987
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
4
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- KODNER ANAL PERIONEAL RETRACTOR
- K Number
- K870897
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Sur-Med Instruments, Inc.
- Date Received
- March 5, 1987
- Decision Date
- June 4, 1987
- Product Code
- FFO
- 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 |
|---|---|---|---|
| FFO | Retractor, Self-Retaining | FDA class 1 | Gastroenterology, Urology |
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