FDA 510(k)
Substantially Equivalent
🇺🇸 United States
PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
K Number: K850207
·
Decision Mar 1, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
31
Review Days
42
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Basic Information
- Device Name
- PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL
- K Number
- K850207
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Syncor Intl. Corp.
- Date Received
- January 18, 1985
- Decision Date
- March 1, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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| K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT | Jun 21, 1985 | Substantially Equivalent |
| K844735 | PTH-RIA | Apr 29, 1985 | Substantially Equivalent |
| K850163 | IRIDIUM 192 WIRES | Mar 26, 1985 | Substantially Equivalent |
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Mar 26, 1985 | Substantially Equivalent |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Mar 26, 1985 | Substantially Equivalent |