The following data is part of a premarket notification filed by Douglas Medical Products Corp. with the FDA for 3 Lead Connector.
Device ID | K931659 |
510k Number | K931659 |
Device Name: | 3 LEAD CONNECTOR |
Classification | Set, Administration, Intravascular |
Applicant | DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Contact | Douglas Medical |
Correspondent | Douglas Medical DOUGLAS MEDICAL PRODUCTS CORP. 345 DUNBAR RD. Mundelein, IL 60060 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-05 |
Decision Date | 1994-01-07 |