FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTOMATED BIOPSY DEVICE, MODIFICATION
K Number: K913815
·
Decision Oct 30, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
10
Applicant Total
4
Review Days
65
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Basic Information
- Device Name
- AUTOMATED BIOPSY DEVICE, MODIFICATION
- K Number
- K913815
- 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
- Hart Enterprises, Inc.
- Date Received
- August 26, 1991
- Decision Date
- October 30, 1991
- Product Code
- DWO
- 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 |
|---|---|---|---|
| DWO | Needle, Biopsy, Cardiovascular | FDA class 1 | General, Plastic Surgery |
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