MODIFICATION TO MALE TO MALE LUER ADAPTER
FDA 510(k) clearance K003712 · decided 2001-05-16
Clearance details
- K-number
- K003712
- Device name
- MODIFICATION TO MALE TO MALE LUER ADAPTER
- Applicant
- Molded Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-12-01
- Decision date
- 2001-05-16
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- KOC
- 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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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemod recall (Z-1679-2017) | Molded Products Inc | 2017-03-24 |
| Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medi recall (Z-0969-2013) | Molded Products Inc | 2013-03-18 |