The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Deknatel Thoracic Catheter.
Device ID | K852041 |
510k Number | K852041 |
Device Name: | DEKNATEL THORACIC CATHETER |
Classification | Catheter And Tip, Suction |
Applicant | PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
Contact | Sheldon Steinberg |
Correspondent | Sheldon Steinberg PFIZER, INC. 235 E 42ND ST. Ny, NY 10017 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-09 |
Decision Date | 1985-06-17 |