The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Bag Decanter.
Device ID | K972134 |
510k Number | K972134 |
Device Name: | BAG DECANTER |
Classification | Set, I.v. Fluid Transfer |
Applicant | REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta, GA 30005 |
Contact | Don Rosvold |
Correspondent | Don Rosvold REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta, GA 30005 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-06 |
Decision Date | 1997-08-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BAG DECANTER 73610527 not registered Dead/Abandoned |
MEDI-PLAST INTERNATIONAL, INC. 1986-07-21 |