FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREAST LESION LOCALIZATION NEEDLE
K Number: K924270
·
Decision Sep 23, 1992
Classifications
1
FEI Numbers
236
Registration Numbers
236
Same Product Code
27
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- BREAST LESION LOCALIZATION NEEDLE
- K Number
- K924270
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core Medical, Inc.
- Date Received
- August 24, 1992
- Decision Date
- September 23, 1992
- Product Code
- GDF
- 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 |
|---|---|---|---|
| GDF | Guide, Needle, Surgical | FDA class 1 | General, Plastic Surgery |
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