FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BOWEN ELECTRODE SKIN PREPATORY CLEANSER
K Number: K896898
·
Decision Apr 4, 1990
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
24
Applicant Total
14
Review Days
117
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Basic Information
- Device Name
- BOWEN ELECTRODE SKIN PREPATORY CLEANSER
- K Number
- K896898
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Bowen & Company, Inc.
- Date Received
- December 8, 1989
- Decision Date
- April 4, 1990
- 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
Other 510(k) clearances with the same product code (LKB), ordered by most recent decision date.
PREVANTICS DEVICE SWAB
FDA 510(k)
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BD ALCOHOL SWAB
FDA 510(k)
FDA Unclassified
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SITESCRUB IPA DEVICE
FDA 510(k)
FDA Unclassified
·Unknown
I.V. STARR KIT
FDA 510(k)
FDA Unclassified
·Unknown
STERI-SWAB
FDA 510(k)
FDA Unclassified
·Unknown
HEXIDIS ALCOHOL SWAB
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Bowen & Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896538 | DISPOSABLE 45 DEGREE SHAVER | Dec 6, 1989 | Substantially Equivalent |
| K873766 | STERNAL POWER AWL | Nov 14, 1988 | Substantially Equivalent |
| K872098 | CREMEEN ALVEOLAR BONE CALIPER | Jul 31, 1987 | Substantially Equivalent |
| K871325 | BOWEN REUSEABLE/DISPOSABLE ELECTRODE | Jun 8, 1987 | Substantially Equivalent |
| K870882 | 45 DEGREE SHAVER | Mar 23, 1987 | Substantially Equivalent |
| K870881 | LOOSE BODY GRASPERS | Mar 23, 1987 | Substantially Equivalent |
| K863146 | BOWEN SUTURE PASSER | Sep 5, 1986 | Substantially Equivalent |
| K863148 | BOWEN KNOT PASSER | Sep 5, 1986 | Substantially Equivalent |
| K863149 | BOWEN PROBE | Sep 5, 1986 | Substantially Equivalent |
| K863147 | GLENOID DRILL | Sep 5, 1986 | Substantially Equivalent |