FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NELSON-JUNG PLEURAL CATH
K Number: K854812
·
Decision Feb 11, 1986
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
16
Applicant Total
35
Review Days
70
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Basic Information
- Device Name
- NELSON-JUNG PLEURAL CATH
- K Number
- K854812
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Research Medical, Inc.
- Date Received
- December 3, 1985
- Decision Date
- February 11, 1986
- Product Code
- GBW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBW | Catheter, Peritoneal | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K960098 | RMI INTERNAL MAMMARY ARTERY CANNULA | Mar 26, 1996 | Substantially Equivalent |
| K951344 | RMI HEMOCONCENTRATOR | Aug 15, 1995 | Substantially Equivalent |
| K922083 | RMI SURGICCAL SITE VISUALIZATION WAND | Jan 29, 1993 | Substantially Equivalent |
| K920936 | RMI EXTERNAL CORONARY ARTERY OCCLUDER | Dec 18, 1992 | Substantially Equivalent |
| K915869 | RMI NORMOCLUDER CORONARY ARTERY OCCLUDER | Dec 8, 1992 | Substantially Equivalent |
| K920676 | RMI SOFCLAMP | Apr 15, 1992 | Substantially Equivalent |
| K910221 | RMI VASCULAR TOURNIQUET KIT | May 16, 1991 | Substantially Equivalent |