MALE EXTERNAL CATHETER— 510(k) K923136
Substantially EquivalentRochester Medical Corp.
FDA 510(k) clearance K923136 for MALE EXTERNAL CATHETER, Substantially Equivalent on 1992-12-03. Applicant: Rochester Medical Corp.. Device class: 1.
Clearance details
- Applicant
- Rochester Medical Corp.
- Product code
- Code EXJ
- Device class
- Class 1
- Regulation
- 21 CFR 876.5250
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stewartville, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.