MINNOW PENILE IMPLANT PROTECTOR
FDA 510(k) clearance K904262 · decided 1990-12-13
Clearance details
- K-number
- K904262
- Device name
- MINNOW PENILE IMPLANT PROTECTOR
- Applicant
- Ruja-Med Medical Marketing
- Decision
- Substantially Equivalent
- Date received
- 1990-09-14
- Decision date
- 1990-12-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FAE
- Device class
- 2
- Regulation number
- 876.3630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Coral Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.