The following data is part of a premarket notification filed by C. B. Dumont Company, Inc. with the FDA for Multiple I.v. Sets.
Device ID | K854804 |
510k Number | K854804 |
Device Name: | MULTIPLE I.V. SETS |
Classification | Set, Administration, Intravascular |
Applicant | C. B. DUMONT COMPANY, INC. P.O. BOX 418 Newport, RI 02840 |
Contact | Bertrand Dumont |
Correspondent | Bertrand Dumont C. B. DUMONT COMPANY, INC. P.O. BOX 418 Newport, RI 02840 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-02 |
Decision Date | 1986-02-12 |