FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REJOYN PENILE SUPPORT SYSTEM
K Number: K971576
·
Decision Oct 16, 1997
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
86
Applicant Total
1
Review Days
174
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Basic Information
- Device Name
- REJOYN PENILE SUPPORT SYSTEM
- K Number
- K971576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5020
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Medtech
- Date Received
- April 25, 1997
- Decision Date
- October 16, 1997
- 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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