DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
FDA 510(k) clearance K010712 · decided 2001-09-27
Clearance details
- K-number
- K010712
- Device name
- DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
- Applicant
- Molded Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-09
- Decision date
- 2001-09-27
- Days to decision
- 202 days
- Clearance type
- Abbreviated
- Product code
- FID
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harlan, IA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TUBING, DIALYSATE (AND CONNECTOR) (K022068) | Molded Products, Inc. | 2002-09-23 |
| TYGON M-60/TYGON M-70 (K770299) | Norton Performance Plastics Corp. | 1977-03-16 |
Recalls involving this device
No recalls on record reference this clearance.