FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K Number: K983869
·
Decision Nov 30, 1998
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
72
Applicant Total
5
Review Days
28
Basic Information
- Device Name
- DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
- K Number
- K983869
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- CALTECH INDUSTRIES, INC.
- Date Received
- November 2, 1998
- Decision Date
- November 30, 1998
- 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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Other Clearances by CALTECH INDUSTRIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K982985 | CITREX HOSPITAL SPRAY DISINFECTANT | Nov 2, 1998 | Substantially Equivalent |
| K952405 | CITRACE HOSPITAL GERMICIDAL DEODORIZER | Aug 28, 1995 | Substantially Equivalent |
| K952336 | DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH | Aug 28, 1995 | Substantially Equivalent |
| K951512 | PRECISE HOSPITAL FOAM CLEANER DISINFECTANT | Aug 7, 1995 | Substantially Equivalent |