FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LONZA FORMULATION R-82
K Number: K932277
·
Decision May 12, 1994
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
72
Applicant Total
19
Review Days
365
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Basic Information
- Device Name
- LONZA FORMULATION R-82
- K Number
- K932277
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Calgon Vestal Div.
- Date Received
- May 12, 1993
- Decision Date
- May 12, 1994
- 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 Calgon Vestal Div.
| K Number | Device Name | ||
|---|---|---|---|
| K944494 | ALSA-KLENZ | Oct 19, 1994 | Substantially Equivalent |
| K944033 | BILL EVANS-KLENZ | Oct 7, 1994 | Substantially Equivalent |
| K942270 | SAF-GEL HYDRATING DERMAL WOUND DRESSING | Aug 4, 1994 | Substantially Equivalent |
| K931477 | AMERSE | Jun 17, 1994 | Substantially Equivalent |
| K931816 | VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM | May 26, 1994 | Substantially Equivalent |
| K931342 | LPH | May 26, 1994 | Substantially Equivalent |
| K941163 | MON-KLENZ | May 18, 1994 | Substantially Equivalent |
| K931573 | VESPHENE II | May 16, 1994 | Substantially Equivalent |
| K931599 | HYDRASORB STERILE DRESSING | Jul 8, 1993 | Substantially Equivalent |
| K926034 | EPI-LOCK WOUND DRESSING | Apr 20, 1993 | Substantially Equivalent |