FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇹 Italy
PROGUARD, RR-1, RR-2
K Number: K982832
·
Decision Dec 23, 1998
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
78
Applicant Total
3
Review Days
133
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Basic Information
- Device Name
- PROGUARD, RR-1, RR-2
- K Number
- K982832
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Emerson & Co. Srl
- Date Received
- August 12, 1998
- Decision Date
- December 23, 1998
- Product Code
- LZC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LZC | Medical Glove, Specialty | FDA class 1 | General Hospital |
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