FDA 510(k)
Substantially Equivalent
🇺🇸 United States
SDI C-FLEX STERILE LIGHT HANDLE
K Number: K834239
·
Decision Apr 25, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
10
Review Days
141
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SDI C-FLEX STERILE LIGHT HANDLE
- K Number
- K834239
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Sterile Design, Inc.
- Date Received
- December 6, 1983
- Decision Date
- April 25, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Sterile Design, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K934688 | STERILE DESIGN | Mar 16, 1994 | Unknown |
| K841960 | CARDIO METRICS INVASIVE PRESSURE MONIT | Nov 8, 1985 | Substantially Equivalent |
| K842356 | CUSTOM STERILE PROCEDURE KITS | Mar 21, 1985 | Substantially Equivalent |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Oct 19, 1984 | Substantially Equivalent |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Oct 15, 1984 | Substantially Equivalent |
| K842351 | STERILE DESIGN-CUSTOM STERILE IV KIT | Oct 15, 1984 | Substantially Equivalent |
| K834237 | GRADUATED GUIDE WIRE BOWL 8 | Feb 4, 1984 | Substantially Equivalent |
| K813437 | PAN SET | Dec 31, 1981 | Substantially Equivalent |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Oct 2, 1979 | Substantially Equivalent |