FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLE COUNTER-SURE COUNT/100 COUNT
K Number: K801259
·
Decision Jun 9, 1980
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
17
Review Days
12
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Basic Information
- Device Name
- NEEDLE COUNTER-SURE COUNT/100 COUNT
- K Number
- K801259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Kleen Test Products
- Date Received
- May 28, 1980
- Decision Date
- June 9, 1980
- 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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Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
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Other Clearances by Kleen Test Products
| K Number | Device Name | ||
|---|---|---|---|
| K890039 | KLEEN TEST BASIN SET | Oct 24, 1989 | Substantially Equivalent |
| K890539 | SURE COUNT LIGHT HANDLE COVER | Feb 27, 1989 | Substantially Equivalent |
| K890098 | KLEEN TEST O.R. KIT | Jan 24, 1989 | Substantially Equivalent |
| K853622 | SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 | Oct 10, 1985 | Substantially Equivalent |
| K853454 | SURE COUNT 5 & 10 SPONGE COUNTER | Sep 5, 1985 | Substantially Equivalent |
| K853315 | CAUTERY TIP CLEANING PAD | Aug 21, 1985 | Substantially Equivalent |
| K852258 | SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER | Jun 27, 1985 | Substantially Equivalent |
| K852257 | SURE-COUNT 15 COUNT NEEDLE COUNTER | Jun 26, 1985 | Substantially Equivalent |
| K844199 | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET | Nov 7, 1984 | Substantially Equivalent |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | Jun 9, 1982 | Substantially Equivalent |