FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CN GAURD, STERILE LATEX SURGICAL GLOVES
K Number: K896322
·
Decision Jul 12, 1990
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
18
Applicant Total
4
Review Days
253
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Basic Information
- Device Name
- CN GAURD, STERILE LATEX SURGICAL GLOVES
- K Number
- K896322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4680
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- C.N. Technocrats
- Date Received
- November 1, 1989
- Decision Date
- July 12, 1990
- Product Code
- FGO
- 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 |
|---|---|---|---|
| FGO | Dislodger, Stone, Flexible | FDA class 2 | Gastroenterology, Urology |
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