The following data is part of a premarket notification filed by Deville Laboratories, Inc. with the FDA for I.v. Link.
Device ID | K933366 |
510k Number | K933366 |
Device Name: | I.V. LINK |
Classification | Stretcher, Wheeled |
Applicant | DEVILLE LABORATORIES, INC. 9986 NORTH NEWPORT HIGHWAY SUITE 165 Spokane, WA 99218 |
Contact | Trina Starkey |
Correspondent | Trina Starkey DEVILLE LABORATORIES, INC. 9986 NORTH NEWPORT HIGHWAY SUITE 165 Spokane, WA 99218 |
Product Code | FPO |
CFR Regulation Number | 880.6910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-09 |
Decision Date | 1994-01-10 |