FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K Number: K003323
·
Decision Jan 22, 2001
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
50
Review Days
90
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Basic Information
- Device Name
- COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
- K Number
- K003323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Davol, Inc.
- Date Received
- October 24, 2000
- Decision Date
- January 22, 2001
- Product Code
- FTL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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| K931899 | DAVOL ATS | Nov 15, 1994 | Substantially Equivalent |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | Jun 14, 1994 | Substantially Equivalent |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Mar 25, 1994 | Substantially Equivalent |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | Mar 7, 1994 | Substantially Equivalent |
| K926479 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | Mar 1, 1994 | Substantially Equivalent |