FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCOPEJOCKEY
K Number: K940780
·
Decision May 10, 1994
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
5
Applicant Total
2
Review Days
77
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Basic Information
- Device Name
- SCOPEJOCKEY
- K Number
- K940780
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fibertech Instruments, Inc.
- Date Received
- February 22, 1994
- Decision Date
- May 10, 1994
- Product Code
- OCU
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| OCU | Endoscopic Storage Cover | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Fibertech Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951713 | BUTTON LUBRICATOR | Apr 25, 1995 | Substantially Equivalent |