FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERILE DISPOSABLE SPINAL NEEDLES
K Number: K834407
·
Decision Mar 19, 1984
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
13
Review Days
96
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Basic Information
- Device Name
- STERILE DISPOSABLE SPINAL NEEDLES
- K Number
- K834407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Hydro-Med Products, Inc.
- Date Received
- December 14, 1983
- Decision Date
- March 19, 1984
- 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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|---|---|---|---|
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| K923099 | X-RAY DRAPES | Oct 15, 1992 | Substantially Equivalent |
| K863872 | TAMPER HAMPER | Feb 10, 1987 | Substantially Equivalent |
| K853281 | EASYTOP | Aug 21, 1985 | Substantially Equivalent |
| K842304 | THE PATHFINDER | Aug 1, 1984 | Substantially Equivalent |
| K812405 | STERILE TV CAMERA & CORD COVER | Oct 20, 1981 | Substantially Equivalent |
| K790659 | INFANT SCALE DISPOSABLE LINER | Apr 30, 1979 | Substantially Equivalent |