FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMOGUARD, P2 HIRISK
K Number: K952274
·
Decision Aug 29, 1995
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
8
Review Days
106
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Basic Information
- Device Name
- CHEMOGUARD, P2 HIRISK
- K Number
- K952274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biosafety Systems, Inc.
- Date Received
- May 15, 1995
- Decision Date
- August 29, 1995
- 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 Biosafety Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944514 | P2 NITRILE EXAM GLOVES | Nov 28, 1994 | Substantially Equivalent |
| K944095 | P2 NITRILE EXAM GLOVES | Oct 28, 1994 | Substantially Equivalent |
| K944142 | P2 EXAM GLOVES | Oct 28, 1994 | Substantially Equivalent |
| K921313 | AEROSTAR | Sep 11, 1992 | Substantially Equivalent |
| K904130 | CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL) | Oct 10, 1990 | Substantially Equivalent |
| K901411 | CHEMOPLUS GLOVE | Jun 7, 1990 | Substantially Equivalent |
| K900368 | P2/CHEMO PLUS GLOVES | Mar 8, 1990 | Substantially Equivalent |