The following data is part of a premarket notification filed by Van Dellen, Ltd. with the FDA for Van Dellen Healon Cannula.
Device ID | K873164 |
510k Number | K873164 |
Device Name: | VAN DELLEN HEALON CANNULA |
Classification | Cannula, Ophthalmic |
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 | HMX |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-11 |
Decision Date | 1987-09-04 |