The following data is part of a premarket notification filed by Bd Medical-medical Surgical Systems with the FDA for Protector, Injector, Connector.
Device ID | K120384 |
510k Number | K120384 |
Device Name: | PROTECTOR, INJECTOR, CONNECTOR |
Classification | Set, I.v. Fluid Transfer |
Applicant | BD MEDICAL-MEDICAL SURGICAL SYSTEMS 1 Becton Drive Franklin Lakes, NJ 07417 |
Contact | John Roberts |
Correspondent | John Roberts BD MEDICAL-MEDICAL SURGICAL SYSTEMS 1 Becton Drive Franklin Lakes, NJ 07417 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-07 |
Decision Date | 2012-09-12 |
Summary: | summary |