FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
LI VASECTOMY
K Number: K932465
·
Decision Mar 2, 1994
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
43
Applicant Total
2
Review Days
285
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Basic Information
- Device Name
- LI VASECTOMY
- K Number
- K932465
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.4730
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Femcare , Ltd.
- Date Received
- May 21, 1993
- Decision Date
- March 2, 1994
- Product Code
- KOA
- 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 |
|---|---|---|---|
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Femcare , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K884061 | ADD-A-CATH | Oct 25, 1988 | Substantially Equivalent |