URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
FDA 510(k) clearance K962652 · decided 1996-10-04
Clearance details
- K-number
- K962652
- Device name
- URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- Applicant
- Customed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-07-08
- Decision date
- 1996-10-04
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KNX
- Device class
- 2
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fajardo, PR, US
- Third-party review
- No
- Expedited review
- No
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