FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIERMAN BIOPSY NEEDLE
K Number: K841299
·
Decision May 2, 1984
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
47
Applicant Total
8
Review Days
33
Basic Information
- Device Name
- BIERMAN BIOPSY NEEDLE
- K Number
- K841299
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- POPPER & SONS, INC.
- Date Received
- March 30, 1984
- Decision Date
- May 2, 1984
- 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 POPPER & SONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K911397 | HYPODERMIC NEEDLES, SINGLE LUMEN | May 20, 1991 | Substantially Equivalent |
| K843830 | J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI | Oct 26, 1984 | Substantially Equivalent |
| K843690 | ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE | Oct 25, 1984 | Substantially Equivalent |
| K842406 | WESCOTT TYPE BIOPSY NEEDLE | Aug 9, 1984 | Substantially Equivalent |
| K841301 | GARDNER TYPE BONE MARROW NEEDLE | Jun 5, 1984 | Substantially Equivalent |
| K841300 | ANTRUM NEEDLE-WOLF TYPE | Jun 5, 1984 | Substantially Equivalent |
| K840168 | WESTERMAN-JENSEN BIOPSY NEEDLE | Mar 12, 1984 | Substantially Equivalent |