FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
K Number: K951265
·
Decision Apr 10, 1995
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
151
Applicant Total
191
Review Days
20
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Basic Information
- Device Name
- MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2)
- K Number
- K951265
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5150
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sherwood Medical Co.
- Date Received
- March 21, 1995
- Decision Date
- April 10, 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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Other Clearances by Sherwood Medical Co.
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|---|---|---|---|
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| K954429 | KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT | Mar 8, 1996 | Unknown |
| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
| K950201 | ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER | Dec 15, 1995 | Substantially Equivalent |