FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NYLON THREADED NEEDLE
K Number: K042367
·
Decision Oct 14, 2004
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
1
Review Days
44
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Basic Information
- Device Name
- NYLON THREADED NEEDLE
- K Number
- K042367
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aros Surgical Instruments Corp.
- Date Received
- August 31, 2004
- Decision Date
- October 14, 2004
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
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