The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Cadd Medication Cassette Reservoir.
Device ID | K081156 |
510k Number | K081156 |
Device Name: | CADD MEDICATION CASSETTE RESERVOIR |
Classification | Set, Administration, Intravascular |
Applicant | SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | David H Short |
Correspondent | David H Short SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-23 |
Decision Date | 2008-07-18 |
Summary: | summary |