The following data is part of a premarket notification filed by Specialty Health Products, Inc. with the FDA for Modification To: Liftloc Saftey Infusion Set.
Device ID | K042234 |
510k Number | K042234 |
Device Name: | MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET |
Classification | Set, Administration, Intravascular |
Applicant | SPECIALTY HEALTH PRODUCTS, INC. 585 WEST 500 SOUTH Bountiful, UT 84010 |
Contact | Mark Nelson |
Correspondent | Mark Nelson SPECIALTY HEALTH PRODUCTS, INC. 585 WEST 500 SOUTH Bountiful, UT 84010 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-18 |
Decision Date | 2004-09-08 |
Summary: | summary |