FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
K Number: K862722
·
Decision Aug 11, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
3
Review Days
25
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Basic Information
- Device Name
- TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
- K Number
- K862722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Mercury Enterprises, Inc.
- Date Received
- July 17, 1986
- Decision Date
- August 11, 1986
- Product Code
- FKY
- 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 |
|---|---|---|---|
| FKY | Connector, Tubing, Dialysate | FDA class 2 | Gastroenterology, Urology |
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