FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMUKIN 50% - AIRSPRAY(R)
K Number: K885037
·
Decision Oct 19, 1990
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
15
Applicant Total
1
Review Days
683
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Basic Information
- Device Name
- AMUKIN 50% - AIRSPRAY(R)
- K Number
- K885037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Bernard J. Cooney, P.A.
- Date Received
- December 5, 1988
- Decision Date
- October 19, 1990
- Product Code
- FKO
- 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 |
|---|---|---|---|
| FKO | Catheter, Peritoneal Dialysis, Single Use | FDA class 2 | Gastroenterology, Urology |
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