The following data is part of a premarket notification filed by Medcomp with the FDA for Pro-picc.
Device ID | K091953 |
510k Number | K091953 |
Device Name: | PRO-PICC |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
Contact | Jean Callow |
Correspondent | Jean Callow MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-01 |
Decision Date | 2009-09-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRO-PICC 78646170 3276923 Live/Registered |
Medical Components, Inc. 2005-06-08 |