FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS
K Number: K950340
·
Decision Jun 2, 1995
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
108
Applicant Total
12
Review Days
126
Basic Information
- Device Name
- IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS
- K Number
- K950340
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BEMIS MFG. CO.
- Date Received
- January 27, 1995
- Decision Date
- June 2, 1995
- 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 BEMIS MFG. CO.
| K Number | Device Name | ||
|---|---|---|---|
| K020921 | NO-POKES NEEDLE SAFETY DEVICE | Jul 11, 2002 | Substantially Equivalent |
| K965248 | BEMIS TWO GALLON SHARPS CONTAINER | Feb 14, 1997 | Substantially Equivalent |
| K964858 | BEMIS TWO GALLON CHEMOTHERAPY CONTAINER | Feb 11, 1997 | Substantially Equivalent |
| K960525 | BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100) | Mar 28, 1996 | Substantially Equivalent |
| K953797 | SHARPS DISPOSAL CONTAINERS | Nov 27, 1995 | Substantially Equivalent |
| K941665 | SHARPS DISPOSAL CONTAINER/PHLEBOTOMY | May 23, 1994 | Substantially Equivalent |
| K931664 | SHARPS DISPOSABLE CONTAINERS | May 23, 1994 | Substantially Equivalent |
| K941664 | SHARP DISPOSAL CONTAINERS WALL SAFE | May 23, 1994 | Substantially Equivalent |
| K914601 | SUCTION CONNECTING TUBING | Feb 7, 1992 | Substantially Equivalent |
| K911576 | CHEMOTHERAPY CONTAINER | Jul 5, 1991 | Substantially Equivalent |