FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRESENIUS STERILE STAY SAFE CAP
K Number: K083542
·
Decision Dec 29, 2008
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
42
Review Days
31
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Basic Information
- Device Name
- FRESENIUS STERILE STAY SAFE CAP
- K Number
- K083542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Medical Care North America
- Date Received
- November 28, 2008
- Decision Date
- December 29, 2008
- Product Code
- KDJ
- 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 |
|---|---|---|---|
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | FDA class 2 | Gastroenterology, Urology |
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staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; staysafe® catheter extension set with Luer-Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 18 inch; staysafe® to Luer-Lock Adapter, 4 inch
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