The following data is part of a premarket notification filed by Cumes-honikman Partnership with the FDA for Cumevac.
Device ID | K874410 |
510k Number | K874410 |
Device Name: | CUMEVAC |
Classification | Evacuator, Bladder, Manually Operated |
Applicant | CUMES-HONIKMAN PARTNERSHIP 927 N. KELLOGG AVE. Santa Barbara, CA 93111 |
Contact | C Honikman |
Correspondent | C Honikman CUMES-HONIKMAN PARTNERSHIP 927 N. KELLOGG AVE. Santa Barbara, CA 93111 |
Product Code | FFD |
CFR Regulation Number | 876.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-28 |
Decision Date | 1987-12-03 |