FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
K Number: K952275
·
Decision Oct 11, 1995
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
9
Review Days
149
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Basic Information
- Device Name
- GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB
- K Number
- K952275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Global Medical Prods, Inc.
- Date Received
- May 15, 1995
- Decision Date
- October 11, 1995
- Product Code
- BSP
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K934256 | GLOBAL MEDICAL CUTTING BIOPSY NEEDLE | Mar 28, 1994 | Substantially Equivalent |
| K871556 | MERIVAARA EMERGENCY PATIENT TROLLEY #436 | Apr 30, 1987 | Substantially Equivalent |
| K863748 | HOSPITAL BED | Oct 9, 1986 | Substantially Equivalent |
| K862959 | MERIVAARA PATIENT TROLLEY - MODEL #416 | Sep 25, 1986 | Substantially Equivalent |
| K862957 | MERIVAARA GERIATRIC CHAIR MODEL 455 | Aug 21, 1986 | Substantially Equivalent |
| K862931 | MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 | Aug 7, 1986 | Substantially Equivalent |