FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELLS JOHNSON FIXATION SYSTEM
K Number: K945500
·
Decision Sep 21, 1995
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
15
Review Days
316
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Basic Information
- Device Name
- WELLS JOHNSON FIXATION SYSTEM
- K Number
- K945500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wells Johnson Co.
- Date Received
- November 9, 1994
- Decision Date
- September 21, 1995
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Wells Johnson Co.
| K Number | Device Name | ||
|---|---|---|---|
| K991437 | WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 | Aug 30, 1999 | Substantially Equivalent |
| K984448 | BIRCOLL BALLOON DISSECTOR | Jan 28, 1999 | Substantially Equivalent |
| K971580 | UAS ULTRASONIC ASPIRATOR SYSTEM | Dec 9, 1997 | Substantially Equivalent |
| K945876 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Dec 4, 1995 | Substantially Equivalent |
| K951519 | WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT | Jun 14, 1995 | Substantially Equivalent |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Mar 2, 1995 | Substantially Equivalent |
| K945805 | WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE | Dec 13, 1994 | Substantially Equivalent |
| K854068 | EXTERNAL MECHANICAL FASTENER | Nov 22, 1985 | Substantially Equivalent |
| K843188 | WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP | Sep 20, 1984 | Substantially Equivalent |
| K832520 | SUCTION TIPS | Oct 20, 1983 | Substantially Equivalent |