FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
APLICARE ALCOHOL PREP PAD
K Number: K833182
·
Decision Oct 27, 1983
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
9
Review Days
38
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Basic Information
- Device Name
- APLICARE ALCOHOL PREP PAD
- K Number
- K833182
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Aplicare, Inc.
- Date Received
- September 19, 1983
- Decision Date
- October 27, 1983
- Product Code
- LKB
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LKB | Pad, Alcohol, Device Disinfectant | FDA unclassified | Unknown |
Similar 510(k) Clearances
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Other Clearances by Aplicare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923299 | APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK | Jan 18, 1994 | Substantially Equivalent |
| K895039 | STERILE SALINE - FOR SUCTION CATHETER LUBRICATION | Oct 3, 1989 | Substantially Equivalent |
| K873563 | APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY | Nov 23, 1987 | Substantially Equivalent |
| K861557 | APLICARE SKIN PROTECTANT PREP PAD | Jul 11, 1986 | Substantially Equivalent |
| K861558 | APLICARE SKIN PROTECTANT SWABSTICK | Jun 4, 1986 | Substantially Equivalent |
| K833183 | APLICARE ONE ACETONE ALCOHOL SWABSTICK | Oct 31, 1983 | Substantially Equivalent |
| K833185 | ACETONE ALCOHOL PREP PAD | Oct 31, 1983 | Substantially Equivalent |
| K833184 | APLICARE THREE ALCOHOL SWABSTICKS | Oct 27, 1983 | Substantially Equivalent |