The following data is part of a premarket notification filed by Sorex Medical with the FDA for Picc-fix.
Device ID | K911070 |
510k Number | K911070 |
Device Name: | PICC-FIX |
Classification | Device, Intravascular Catheter Securement |
Applicant | SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
Contact | Joseph Sorenson |
Correspondent | Joseph Sorenson SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-11 |
Decision Date | 1991-07-05 |