FDA 510(k)
Substantially Equivalent
🇺🇸 United States
STERILE BIOPSY NEEDLES
K Number: K853559
·
Decision Sep 11, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
6
Review Days
16
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Basic Information
- Device Name
- STERILE BIOPSY NEEDLES
- K Number
- K853559
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Plasmedics, Inc.
- Date Received
- August 26, 1985
- Decision Date
- September 11, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Plasmedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850263 | PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLY | Mar 25, 1985 | Substantially Equivalent |
| K831601 | APNEA ALARM FOR ADULT-PEDIATRIC & NEON | Sep 26, 1983 | Substantially Equivalent |
| K831650 | ANESTHESIA/RESPIRATORY DISCONNECT - | Sep 12, 1983 | Substantially Equivalent |
| K830604 | WEDGE PRESSURE CATHETER | Jul 18, 1983 | Substantially Equivalent |
| K823351 | CENTRAL VENOUS CATHETER | Dec 9, 1982 | Substantially Equivalent |