FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR
K Number: K894653
·
Decision Dec 21, 1989
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
1
Review Days
150
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Basic Information
- Device Name
- NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR
- K Number
- K894653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Superior Biosystems, Inc.
- Date Received
- July 24, 1989
- Decision Date
- December 21, 1989
- Product Code
- KGC
- 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 |
|---|---|---|---|
| KGC | Tube, Gastro-Enterostomy | FDA class 2 | Gastroenterology, Urology |
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