FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
K Number: K960933
·
Decision Aug 28, 1996
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
174
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Basic Information
- Device Name
- BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
- K Number
- K960933
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Plexus, Inc.
- Date Received
- March 7, 1996
- Decision Date
- August 28, 1996
- 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 Bio-Plexus, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003827 | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION | Jan 8, 2001 | Substantially Equivalent |
| K992091 | PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 | Sep 9, 1999 | Substantially Equivalent |
| K963748 | BIO-PLEXUS DROP-IT NEEDLE HOLDER | Jun 6, 1997 | Substantially Equivalent |
| K961251 | PUNCTUR-GUARD WINGED SET | Jun 27, 1996 | Substantially Equivalent |
| K895024 | PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE | Sep 21, 1990 | Substantially Equivalent |