FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SNAP-LOCK ADDITIVE CAP #SL400
K Number: K854033
·
Decision Nov 6, 1985
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
5
Review Days
36
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Basic Information
- Device Name
- SNAP-LOCK ADDITIVE CAP #SL400
- K Number
- K854033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Williams Medical Co.
- Date Received
- October 1, 1985
- Decision Date
- November 6, 1985
- Product Code
- KPE
- 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 |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
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Other Clearances by Williams Medical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K891159 | SODIUM BICARBONATE, U.S.P. | Apr 7, 1989 | Substantially Equivalent |
| K854031 | SNAP-LOCK ADDITIVE CAP #SL100 | Nov 6, 1985 | Substantially Equivalent |
| K854034 | SNAP-LOCK ADDITIVE CAP #SL 300 | Nov 6, 1985 | Substantially Equivalent |
| K854032 | SNAP-LOCK ADDITIVE CAP #SL 200 | Nov 1, 1985 | Substantially Equivalent |