DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
FDA 510(k) clearance K871154 · decided 1987-04-30
Clearance details
- K-number
- K871154
- Device name
- DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
- Applicant
- Delmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-24
- Decision date
- 1987-04-30
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- KDJ
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Freehold, NJ, 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.