The following data is part of a premarket notification filed by Health Line International Corporation with the FDA for Uni-picc.
Device ID | K130034 |
510k Number | K130034 |
Device Name: | UNI-PICC |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014 |
Contact | Nola Benstog |
Correspondent | Nola Benstog HEALTH LINE INTERNATIONAL CORPORATION 803 N. 1250 W. SUITE 1 Centerville, UT 84014 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-07 |
Decision Date | 2013-03-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
UNI-PICC 85623173 4381010 Live/Registered |
Health Line International Corp. 2012-05-11 |