FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPERDERMIC NEEDLE WITH SENSOR #514
K Number: K791462
·
Decision Sep 24, 1979
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
70
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Basic Information
- Device Name
- HYPERDERMIC NEEDLE WITH SENSOR #514
- K Number
- K791462
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medtech Intl., Inc.
- Date Received
- July 16, 1979
- Decision Date
- September 24, 1979
- 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 Medtech Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920876 | CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER | Dec 11, 1992 | Substantially Equivalent |
| K853843 | IV MATE | Jan 9, 1986 | Substantially Equivalent |
| K790467 | SURGICAL EYE SPONGE | Mar 26, 1979 | Substantially Equivalent |
| K790389 | GAUZE & COTTON SPONGES | Mar 26, 1979 | Substantially Equivalent |
| K781157 | STIMULATOR, NERVE, TRANSCUTANEOUS | Sep 20, 1978 | Substantially Equivalent |