FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
K Number: K923299
·
Decision Jan 18, 1994
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
9
Review Days
561
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Basic Information
- Device Name
- APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK
- K Number
- K923299
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aplicare, Inc.
- Date Received
- July 6, 1992
- Decision Date
- January 18, 1994
- Product Code
- KMF
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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Other Clearances by Aplicare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K833182 | APLICARE ALCOHOL PREP PAD | Oct 27, 1983 | Substantially Equivalent |
| K833184 | APLICARE THREE ALCOHOL SWABSTICKS | Oct 27, 1983 | Substantially Equivalent |