The following data is part of a premarket notification filed by Acacia Laboratories, Inc. with the FDA for Sterile Suction Tubing Set.
Device ID | K901761 |
510k Number | K901761 |
Device Name: | STERILE SUCTION TUBING SET |
Classification | Tube, Aspirating, Flexible, Connecting |
Applicant | ACACIA LABORATORIES, INC. 1010 HATHAWAY AVE. Santa Ana, CA 92705 |
Contact | William A Goolsbee |
Correspondent | William A Goolsbee ACACIA LABORATORIES, INC. 1010 HATHAWAY AVE. Santa Ana, CA 92705 |
Product Code | BYY |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-18 |
Decision Date | 1990-05-07 |