FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POINT OF USE II SHARPS-A-GATOR
K Number: K964387
·
Decision Mar 27, 1997
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
55
Review Days
143
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Basic Information
- Device Name
- POINT OF USE II SHARPS-A-GATOR
- K Number
- K964387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Graphic Controls Corp.
- Date Received
- November 4, 1996
- Decision Date
- March 27, 1997
- 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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