FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHARPS TANK REUSABLE SHARPS CONTAINER
K Number: K111085
·
Decision Apr 25, 2012
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
108
Applicant Total
2
Review Days
372
Basic Information
- Device Name
- SHARPS TANK REUSABLE SHARPS CONTAINER
- K Number
- K111085
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- REHRIG PACIFIC COMPANY
- Date Received
- April 19, 2011
- Decision Date
- April 25, 2012
- Product Code
- MMK
- 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 |
|---|---|---|---|
| MMK | Container, Sharps | FDA class 2 | General Hospital |
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Other Clearances by REHRIG PACIFIC COMPANY
| K Number | Device Name | ||
|---|---|---|---|
| K131087 | SHARPSTANK REUSABLE SHARPS CONTAINER | Jul 12, 2013 | Substantially Equivalent |