FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTEC-TOP, STERIDENT, BENTO
K Number: K031022
·
Decision Apr 14, 2003
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
1
Review Days
14
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Basic Information
- Device Name
- PROTEC-TOP, STERIDENT, BENTO
- K Number
- K031022
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ronpak, Inc.
- Date Received
- March 31, 2003
- Decision Date
- April 14, 2003
- Product Code
- FRG
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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