The following data is part of a premarket notification filed by Van Dellen, Ltd. with the FDA for Van Dellen Aspirating Tubing.
Device ID | K873463 |
510k Number | K873463 |
Device Name: | VAN DELLEN ASPIRATING TUBING |
Classification | Tube, Aspirating, Flexible, Connecting |
Applicant | VAN DELLEN, LTD. 3810 E. 44TH ST., SUITE 301 P.O. BOX 27748 Tucson, AZ 85726 |
Contact | Roger Danhof |
Correspondent | Roger Danhof VAN DELLEN, LTD. 3810 E. 44TH ST., SUITE 301 P.O. BOX 27748 Tucson, AZ 85726 |
Product Code | BYY |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-28 |
Decision Date | 1987-11-23 |