The following data is part of a premarket notification filed by Thomson & Shelton Instrumentation Co, Inc. with the FDA for Suction Tip.
Device ID | K893667 |
510k Number | K893667 |
Device Name: | SUCTION TIP |
Classification | Catheter And Tip, Suction |
Applicant | THOMSON & SHELTON INSTRUMENTATION CO, INC. RT.5, BOX 529, PECAN LN. Rockwall, TX 75087 |
Contact | Terrence Thomson |
Correspondent | Terrence Thomson THOMSON & SHELTON INSTRUMENTATION CO, INC. RT.5, BOX 529, PECAN LN. Rockwall, TX 75087 |
Product Code | JOL |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-15 |
Decision Date | 1989-08-21 |