FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAN SET
K Number: K813437
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
10
Review Days
23
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Basic Information
- Device Name
- PAN SET
- K Number
- K813437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sterile Design, Inc.
- Date Received
- December 8, 1981
- Decision Date
- December 31, 1981
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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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 |
| K834239 | SDI C-FLEX STERILE LIGHT HANDLE | Apr 25, 1984 | Substantially Equivalent |
| K834237 | GRADUATED GUIDE WIRE BOWL 8 | Feb 4, 1984 | Substantially Equivalent |
| K791738 | CUSTOM DRESSING CHANGE TRAYS | Oct 2, 1979 | Substantially Equivalent |