FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHARPS DISPOSAL CONTAINERS
K Number: K953797
·
Decision Nov 27, 1995
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
12
Review Days
108
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Basic Information
- Device Name
- SHARPS DISPOSAL CONTAINERS
- K Number
- K953797
- 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
- August 11, 1995
- Decision Date
- November 27, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMK), ordered by most recent decision date.
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong
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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 |
| K950340 | IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS | Jun 2, 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 |