COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
FDA 510(k) clearance K934266 · decided 1994-04-19
Clearance details
- K-number
- K934266
- Device name
- COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
- Applicant
- Sierra Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-31
- Decision date
- 1994-04-19
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- EXJ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tucson, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.