FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APLICARE SKIN PROTECTANT PREP PAD
K Number: K861557
·
Decision Jul 11, 1986
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
2
Applicant Total
9
Review Days
77
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Basic Information
- Device Name
- APLICARE SKIN PROTECTANT PREP PAD
- K Number
- K861557
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Aplicare, Inc.
- Date Received
- April 25, 1986
- Decision Date
- July 11, 1986
- Product Code
- NEC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NEC | Bandage, Liquid, Skin Protectant | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEC), ordered by most recent decision date.
SUPERSKIN
FDA 510(k)
FDA Class 1
·General Hospital
APLICARE SKIN PROTECTANT SWABSTICK
FDA 510(k)
FDA Class 1
·General Hospital
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 |
| 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 |
| K833182 | APLICARE ALCOHOL PREP PAD | Oct 27, 1983 | Substantially Equivalent |
| K833184 | APLICARE THREE ALCOHOL SWABSTICKS | Oct 27, 1983 | Substantially Equivalent |