FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECRMARK BIOPSY SITE MARKING SYSTEM
K Number: K102768
·
Decision Dec 2, 2010
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
109
Applicant Total
116
Review Days
69
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Basic Information
- Device Name
- SECRMARK BIOPSY SITE MARKING SYSTEM
- K Number
- K102768
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- September 24, 2010
- Decision Date
- December 2, 2010
- Product Code
- NEU
- 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 |
|---|---|---|---|
| NEU | Marker, Radiographic, Implantable | FDA class 2 | General, Plastic Surgery |
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