The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ulticare Disposable Syringe 3 Ml/cc.
Device ID | K033794 |
510k Number | K033794 |
Device Name: | ULTICARE DISPOSABLE SYRINGE 3 ML/CC |
Classification | Syringe, Piston |
Applicant | ULTIMED, INC. 188 SUQUAMISH WAY Laconner, WA 98257 |
Contact | Ellen G Redding |
Correspondent | Ellen G Redding ULTIMED, INC. 188 SUQUAMISH WAY Laconner, WA 98257 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-05 |
Decision Date | 2003-12-30 |
Summary: | summary |