FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLE CONTAINER
K Number: K874430
·
Decision Jan 4, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
68
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Basic Information
- Device Name
- NEEDLE CONTAINER
- K Number
- K874430
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- American Medical Technology, Inc.
- Date Received
- October 28, 1987
- Decision Date
- January 4, 1988
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by American Medical Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963808 | CHOICE POWERED WHEELCHAIR | Feb 12, 1997 | Substantially Equivalent |
| K905745 | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM | Apr 23, 1992 | Substantially Equivalent |
| K874567 | RESUSCITATOR | Feb 29, 1988 | Substantially Equivalent |
| K874360 | PLASTIC TUBING CONNECTOR | Nov 17, 1987 | Substantially Equivalent |
| K873313 | SURGICAL DRAPE | Sep 4, 1987 | Substantially Equivalent |