FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLE GUARD(TM)
K Number: K890473
·
Decision Apr 3, 1989
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
7
Review Days
62
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Basic Information
- Device Name
- NEEDLE GUARD(TM)
- K Number
- K890473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Martech Medical Products, Inc.
- Date Received
- January 31, 1989
- Decision Date
- April 3, 1989
- 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 Martech Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960519 | MARTECH ENDOSCOPIC INJECTION NEEDLE | May 1, 1996 | Substantially Equivalent |
| K931924 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Aug 3, 1993 | Substantially Equivalent |
| K922438 | PRO2 OXYGEN ANALYZER | Mar 5, 1993 | Substantially Equivalent |
| K926007 | ACCESSORY TO PISTON SYRINGE | Feb 23, 1993 | Substantially Equivalent |
| K914778 | NEOLINE(TM) | Sep 16, 1992 | Unknown |
| K910970 | MARKSMAN ARTERIAL BLOOD GAS SYRINGE | Oct 15, 1991 | Substantially Equivalent |