The following data is part of a premarket notification filed by Medical Parameters, Inc. with the FDA for I.v. Sets Walrus Brand Various Configur-.
Device ID | K830755 |
510k Number | K830755 |
Device Name: | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- |
Classification | Set, Administration, Intravascular |
Applicant | MEDICAL PARAMETERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-10 |
Decision Date | 1983-04-28 |