FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE
K Number: K800406
·
Decision Mar 12, 1980
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
21
Review Days
15
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Basic Information
- Device Name
- FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE
- K Number
- K800406
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- A.D.T. Lab Industries
- Date Received
- February 26, 1980
- Decision Date
- March 12, 1980
- Product Code
- GDM
- 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by A.D.T. Lab Industries
| K Number | Device Name | ||
|---|---|---|---|
| K812297 | A.D.T. PROCEDURES TRAY | Sep 28, 1981 | Substantially Equivalent |
| K801754 | ADT BONE MARROW ASPIRATION NEEDLE | Aug 20, 1980 | Substantially Equivalent |
| K801753 | ADT BONE MARROW BIOPSY-ASPIR. NEELDE | Aug 20, 1980 | Substantially Equivalent |
| K800410 | ADT BONE MARROW BIOPSY-ASPIRATION TRAY | Apr 28, 1980 | Substantially Equivalent |
| K800417 | ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL | Apr 28, 1980 | Substantially Equivalent |
| K800411 | ASPIRATION TRAY W/FERRIS DISP. ILLINOIS | Apr 28, 1980 | Substantially Equivalent |
| K800418 | ADT DISPOSABLE THIN NEEDLE ASPIRATION | Apr 28, 1980 | Substantially Equivalent |
| K800414 | ADT SOFT TISSUE BIOPSY TRAY | Apr 28, 1980 | Substantially Equivalent |
| K800408 | ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE | Apr 28, 1980 | Substantially Equivalent |
| K800409 | ADT BONE MARROW BIOPSY ASPIRATION TRAY | Apr 28, 1980 | Substantially Equivalent |