FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
SIGMA Sterilization Pouch and Roll
K Number: K180661
·
Decision Jun 5, 2018
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
3
Review Days
83
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Basic Information
- Device Name
- SIGMA Sterilization Pouch and Roll
- K Number
- K180661
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sigma Medical Supplies Corp.
- Date Received
- March 14, 2018
- Decision Date
- June 5, 2018
- 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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