FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES
K Number: K961324
·
Decision Jul 2, 1996
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
9
Applicant Total
9
Review Days
85
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Basic Information
- Device Name
- GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES
- K Number
- K961324
- 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
- April 8, 1996
- Decision Date
- July 2, 1996
- Product Code
- MIA
- 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 |
|---|---|---|---|
| MIA | Needle, Spinal, Short Term | FDA class 2 | Anesthesiology |
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Other Clearances by Global Medical Prods, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962329 | GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 | Sep 12, 1996 | Substantially Equivalent |
| K952275 | GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB | Oct 11, 1995 | Substantially Equivalent |
| 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 |