FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
K Number: K972731
·
Decision Sep 29, 1997
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
112
Applicant Total
5
Review Days
69
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Basic Information
- Device Name
- NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET
- K Number
- K972731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Klein-Baker Medical, Inc.
- Date Received
- July 22, 1997
- Decision Date
- September 29, 1997
- 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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Other Clearances by Klein-Baker Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | May 22, 1997 | Substantially Equivalent |
| K970434 | NEO-PICC | Apr 1, 1997 | Substantially Equivalent |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Dec 24, 1996 | Substantially Equivalent |
| K963867 | NEO-CARE CATHETERIZATION TRAY | Nov 6, 1996 | Substantially Equivalent |