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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20020451331625 | K894206 | 000 |
20020451100887 | K894206 | 000 |
20020451100870 | K894206 | 000 |
20020451100863 | K894206 | 000 |
20020451100856 | K894206 | 000 |
20020451100849 | K894206 | 000 |
20020451100832 | K894206 | 000 |
20020451101723 | K894206 | 000 |
20020451101457 | K894206 | 000 |
20020451101440 | K894206 | 000 |
20020451101433 | K894206 | 000 |
10020451101429 | K894206 | 000 |
20020451101419 | K894206 | 000 |
20020451101709 | K894206 | 000 |
10020451101467 | K894206 | 000 |
20020451100894 | K894206 | 000 |
20020451101198 | K894206 | 000 |
20020451101204 | K894206 | 000 |
20020451331618 | K894206 | 000 |
20020451331601 | K894206 | 000 |
20020451331595 | K894206 | 000 |
20020451331588 | K894206 | 000 |
20020451331571 | K894206 | 000 |
20020451331366 | K894206 | 000 |
20020451331359 | K894206 | 000 |
20020451331342 | K894206 | 000 |
20020451331335 | K894206 | 000 |
20020451331328 | K894206 | 000 |
20020451331311 | K894206 | 000 |
20020451101242 | K894206 | 000 |
20020451101235 | K894206 | 000 |
20020451101228 | K894206 | 000 |
20020451101211 | K894206 | 000 |
10020451101719 | K894206 | 000 |