FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPACE-OR RETRACTOR
K Number: K993544
·
Decision Dec 22, 1999
Classifications
1
FEI Numbers
150
Registration Numbers
150
Same Product Code
4
Applicant Total
4
Review Days
64
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Basic Information
- Device Name
- SPACE-OR RETRACTOR
- K Number
- K993544
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Surgical Concepts (Asc)
- Date Received
- October 19, 1999
- Decision Date
- December 22, 1999
- 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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