FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K Number: K943134
·
Decision Nov 7, 1994
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
8
Review Days
131
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Basic Information
- Device Name
- B-D GUARDIAN NESTABLE SHARPS COLLECTORS
- K Number
- K943134
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Med-Safe Systems, Inc.
- Date Received
- June 29, 1994
- Decision Date
- November 7, 1994
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Med-Safe Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943139 | B-D GUARDIAN ONE PIECE SHARPS COLLECTORS | Nov 28, 1994 | Substantially Equivalent |
| K943138 | VACUTAINER BRAND NEEDLE DISPOSAL CONTAINER | Nov 28, 1994 | Substantially Equivalent |
| K943137 | B-D/BFI MAIL DISPOSAL SERVICE | Nov 7, 1994 | Substantially Equivalent |
| K943141 | B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS | Nov 7, 1994 | Substantially Equivalent |
| K943135 | MED-SAFE INSULIN SHARPS CONTAINER | Nov 7, 1994 | Substantially Equivalent |
| K943136 | B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS | Nov 7, 1994 | Substantially Equivalent |
| K943140 | B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS | Nov 7, 1994 | Substantially Equivalent |