The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Intopo.
Device ID | K894206 |
510k Number | K894206 |
Device Name: | INTOPO |
Classification | Syringe, Piston |
Applicant | ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354 |
Contact | Margaret Lumia |
Correspondent | Margaret Lumia ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-19 |
Decision Date | 1989-10-27 |