FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMNI-II
K Number: K951983
·
Decision Jun 20, 1995
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
72
Applicant Total
9
Review Days
54
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Basic Information
- Device Name
- IMNI-II
- K Number
- K951983
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cottrell, Ltd.
- Date Received
- April 27, 1995
- Decision Date
- June 20, 1995
- Product Code
- LRJ
- 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 |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | FDA class 1 | General Hospital |
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| K945575 | PRO BARRIER(TM) TUBE SOX(TM) | Mar 6, 1995 | Substantially Equivalent |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | Apr 4, 1990 | Substantially Equivalent |