The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for I.v. Start Kit.
Device ID | K931729 |
510k Number | K931729 |
Device Name: | I.V. START KIT |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
Contact | Jerry W Myers |
Correspondent | Jerry W Myers CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow, OK 74012 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-07 |
Decision Date | 1994-02-22 |