The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel Trocar Catheter.
Device ID | K873525 |
510k Number | K873525 |
Device Name: | DEKNATEL TROCAR CATHETER |
Classification | Catheter And Tip, Suction |
Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
Contact | Betty Orofino |
Correspondent | Betty Orofino DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-01 |
Decision Date | 1987-11-02 |