FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
K Number: K973259
·
Decision Sep 10, 1997
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
73
Applicant Total
3
Review Days
12
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Basic Information
- Device Name
- K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
- K Number
- K973259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Creative Technologies, Inc.
- Date Received
- August 29, 1997
- Decision Date
- September 10, 1997
- Product Code
- OCZ
- 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 |
|---|---|---|---|
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | FDA class 2 | Gastroenterology, Urology |
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