FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTRAL WALL DEFECT REDUCT SILO
K Number: K840172
·
Decision Jun 27, 1984
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
13
Review Days
162
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Basic Information
- Device Name
- VENTRAL WALL DEFECT REDUCT SILO
- K Number
- K840172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Heyer Schulte
- Date Received
- January 17, 1984
- Decision Date
- June 27, 1984
- 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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|---|---|---|---|
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| K833704 | AMER. V. MUELLER SURGICALSTAPLES-CARTR | Dec 29, 1983 | Substantially Equivalent |
| K832738 | HEYER-SCHULTE AFTERLOADING CATHETER | Sep 29, 1983 | Substantially Equivalent |
| K823790 | VENTRICULAR ACCESS SYSTEM | Apr 28, 1983 | Substantially Equivalent |
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| K822032 | LARGE VOLUME CLOSED WOUND SUCTION DRAIN | Aug 16, 1982 | Substantially Equivalent |
| K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | Feb 18, 1982 | Substantially Equivalent |
| K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | Jun 26, 1981 | Substantially Equivalent |