The following data is part of a premarket notification filed by Medela Llc with the FDA for Pump In Style.
Device ID | K200508 |
510k Number | K200508 |
Device Name: | Pump In Style |
Classification | Pump, Breast, Powered |
Applicant | Medela LLC 1101 Corporate Drive Mchenry, IL 60050 |
Contact | Pj Pasia |
Correspondent | Pj Pasia Medela LLC 1101 Corporate Drive Mchenry, IL 60050 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-02 |
Decision Date | 2020-06-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10020451412655 | K200508 | 000 |
10020451401468 | K200508 | 000 |
10020451401451 | K200508 | 000 |
10020451401444 | K200508 | 000 |
10020451401437 | K200508 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PUMP IN STYLE 75345375 2198035 Live/Registered |
Medela Holding AG 1997-08-22 |