FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAYEREC SYSTEM(TM)
K Number: K901318
·
Decision May 4, 1990
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
4
Review Days
44
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Basic Information
- Device Name
- STAYEREC SYSTEM(TM)
- K Number
- K901318
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Osbon Medical Systems, Ltd.
- Date Received
- March 21, 1990
- Decision Date
- May 4, 1990
- Product Code
- LKY
- 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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | FDA class 2 | Gastroenterology, Urology |
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