The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for Jms Extension Set With Planecta, Planecta (stand Alone Unit), Planecta Lock & Planecta Adaptor.
| Device ID | K023668 |
| 510k Number | K023668 |
| Device Name: | JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Contact | Swee Cheau Chong |
| Correspondent | Swee Cheau Chong JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-31 |
| Decision Date | 2003-07-01 |