FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NYLAMID MESH PAD FULL & HALF
K Number: K852011
·
Decision Jun 11, 1985
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
16
Review Days
46
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Basic Information
- Device Name
- NYLAMID MESH PAD FULL & HALF
- K Number
- K852011
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- S. Jackson, Inc.
- Date Received
- April 26, 1985
- Decision Date
- June 11, 1985
- Product Code
- FTM
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by S. Jackson, Inc.
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| K931612 | NYLAMID SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K922630 | MOPYLEN | Oct 20, 1992 | Substantially Equivalent |
| K912429 | N80-838 SUPRAMID EXTRA SUTURE | Oct 2, 1991 | Substantially Equivalent |
| K904052 | SUPRAMID EXTRA SUTURES | Oct 25, 1990 | Substantially Equivalent |
| K831725 | FOIL IN 3 FORMS-NON-STERILE SHEETS | Aug 16, 1983 | Substantially Equivalent |
| K831727 | QUARTER GLOBE CAPS | Aug 12, 1983 | Substantially Equivalent |