FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POWDER FREE SURGEON'S GLOVE
K Number: K944054
·
Decision Nov 17, 1994
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- POWDER FREE SURGEON'S GLOVE
- K Number
- K944054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Arent Fox
- Date Received
- August 19, 1994
- Decision Date
- November 17, 1994
- Product Code
- KGD
- 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 |
|---|---|---|---|
| KGD | Scissors For Cystoscope | FDA class 2 | Gastroenterology, Urology |
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