FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LO-CORE NEEDLE
K Number: K882064
·
Decision Jul 8, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
52
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Basic Information
- Device Name
- LO-CORE NEEDLE
- K Number
- K882064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Device Labs, Inc.
- Date Received
- May 17, 1988
- Decision Date
- July 8, 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 Device Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930632 | CHEMOSITE IMPLANTABLE DRUG DELIVERY | Dec 22, 1993 | Substantially Equivalent |
| K904417 | CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM | Dec 5, 1990 | Substantially Equivalent |
| K902135 | PERCUTANEOUS INTRODUCER KIT | Aug 1, 1990 | Unknown |
| K901722 | CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM | Jul 3, 1990 | Substantially Equivalent |
| K883764 | INTRAVASCULAR ADMINISTRATION SET | Dec 19, 1988 | Substantially Equivalent |