FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
K Number: K853601
·
Decision Sep 16, 1985
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
1
Applicant Total
14
Review Days
20
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Basic Information
- Device Name
- MORGAN ARTHROSCOPIC MENESUS & SYNOVIAL RASP
- K Number
- K853601
- 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
- August 27, 1985
- Decision Date
- September 16, 1985
- Product Code
- GAC
- 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 |
|---|---|---|---|
| GAC | Rasp, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAC), ordered by most recent decision date.
View allOther Clearances by Bowen & Company, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |