TYGON M-60/TYGON M-70
FDA 510(k) clearance K770299 · decided 1977-03-16
Clearance details
- K-number
- K770299
- Device name
- TYGON M-60/TYGON M-70
- Applicant
- Norton Performance Plastics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-02-14
- Decision date
- 1977-03-16
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- FID
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
| DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (K010712) | Molded Products, Inc. | 2001-09-27 |
Recalls involving this device
No recalls on record reference this clearance.