FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
E-Z-JECTOR
K Number: K780883
·
Decision Aug 10, 1978
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
5
Applicant Total
2
Review Days
72
Basic Information
- Device Name
- E-Z-JECTOR
- K Number
- K780883
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Harco Products
- Date Received
- May 30, 1978
- Decision Date
- August 10, 1978
- Product Code
- KZA
- 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 |
|---|---|---|---|
| KZA | Device, Vein Location, Liquid Crystal | FDA class 1 | General Hospital |
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Other Clearances by Harco Products
| K Number | Device Name | ||
|---|---|---|---|
| K780884 | HYPO-GRIP | Aug 10, 1978 | Substantially Equivalent |