FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3 PORT LUER
K Number: K770500
·
Decision Apr 5, 1977
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
2
Review Days
21
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Basic Information
- Device Name
- 3 PORT LUER
- K Number
- K770500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Unimetrics Corp.
- Date Received
- March 15, 1977
- Decision Date
- April 5, 1977
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Unimetrics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K760500 | TUBE, HEAVY GLASS WALL INJECTION | Sep 3, 1976 | Substantially Equivalent |