FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
K Number: K942753
·
Decision Nov 2, 1994
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
13
Applicant Total
3
Review Days
145
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Basic Information
- Device Name
- ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER
- K Number
- K942753
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Researched, Novel Medical Devices (Rn/Md)
- Date Received
- June 10, 1994
- Decision Date
- November 2, 1994
- Product Code
- EYZ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | FDA class 1 | Gastroenterology, Urology |
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