FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
45 DEGREE SHAVER
K Number: K870882
·
Decision Mar 23, 1987
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
20
Applicant Total
14
Review Days
18
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Basic Information
- Device Name
- 45 DEGREE SHAVER
- K Number
- K870882
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Bowen & Company, Inc.
- Date Received
- March 5, 1987
- Decision Date
- March 23, 1987
- Product Code
- HTZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| HTZ | Instrument, Cutting, Orthopedic | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Bowen & Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896898 | BOWEN ELECTRODE SKIN PREPATORY CLEANSER | Apr 4, 1990 | Substantially Equivalent |
| 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 |
| 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 |