FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLOOD COLLECTING NEEDLE AND HOLDERS
K Number: K880892
·
Decision Apr 21, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
127
Review Days
50
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Basic Information
- Device Name
- BLOOD COLLECTING NEEDLE AND HOLDERS
- K Number
- K880892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Abco Dealers, Inc.
- Date Received
- March 2, 1988
- Decision Date
- April 21, 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 Abco Dealers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905025 | DIGITAL THERMOMETER KITS | Feb 7, 1991 | Substantially Equivalent |
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| K880894 | ALLERGIST SYRINGES | Mar 31, 1988 | Substantially Equivalent |
| K872875 | STRETCH GAUZE BANDAGES | Sep 4, 1987 | Substantially Equivalent |
| K872874 | MICROSCOPE COVER GLASSES | Aug 10, 1987 | Substantially Equivalent |
| K872797 | NON-SKID SHOE COVERS | Aug 4, 1987 | Substantially Equivalent |
| K871465 | THERMOMETER SHEATHS | May 11, 1987 | Substantially Equivalent |
| K862726 | DISPOSABLE SHOE COVERS AND NURSES CAPS | Aug 1, 1986 | Substantially Equivalent |
| K862111 | ARMBOARDS, REUSABLE AND DISPOSABLE | Jul 8, 1986 | Substantially Equivalent |
| K862112 | MICROSCOPE SLIDES | Jun 13, 1986 | Substantially Equivalent |