The following data is part of a premarket notification filed by Van Dellen, Ltd. with the FDA for Van Dellen Aspirator.
Device ID | K873462 |
510k Number | K873462 |
Device Name: | VAN DELLEN ASPIRATOR |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
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 | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-28 |
Decision Date | 1987-09-25 |