The following data is part of a premarket notification filed by Jms North America Corp. with the FDA for Jms Planecta Stopcock.
| Device ID | K070143 |
| 510k Number | K070143 |
| Device Name: | JMS PLANECTA STOPCOCK |
| Classification | Stopcock, I.v. Set |
| Applicant | JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Contact | Chong Swee Cheau |
| Correspondent | Chong Swee Cheau JMS NORTH AMERICA CORP. 22320 FOOTHILL BLVD., SUITE 350 Hayward, CA 94541 |
| Product Code | FMG |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-04-10 |
| Summary: | summary |