FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASCEND GENERAL PURPOSE DISINFECTANT
K Number: K960582
·
Decision Mar 12, 1996
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
72
Applicant Total
7
Review Days
29
Basic Information
- Device Name
- ASCEND GENERAL PURPOSE DISINFECTANT
- K Number
- K960582
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HUNTINGTON LABORATORIES, INC.
- Date Received
- February 12, 1996
- Decision Date
- March 12, 1996
- 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 HUNTINGTON LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K960583 | MATAR GENERAL PURPOSE DISINFECTANT | Mar 12, 1996 | Substantially Equivalent |
| K960580 | BEAUCOUP GENERAL PURPOSE DISINFECTANT | Mar 12, 1996 | Substantially Equivalent |
| K953009 | FORMULATION HWS-128 EPA REG. NO. 47371-130 | Aug 11, 1995 | Substantially Equivalent |
| K953011 | FORMULATION HWS-64 EPA REG. NO. 47371-131 | Aug 11, 1995 | Substantially Equivalent |
| K953010 | FORMULATION HWS-256 EPA REG. NO. 47371-129 | Aug 11, 1995 | Substantially Equivalent |
| K853653 | SANA-LUBE | Nov 13, 1985 | Substantially Equivalent |