The following data is part of a premarket notification filed by Anatech, Ltd. with the FDA for Dry-form.
Device ID | K872663 |
510k Number | K872663 |
Device Name: | DRY-FORM |
Classification | Formalin, Neutral Buffered |
Applicant | ANATECH, LTD. 1020 HARTS LAKE RD. Battle Creek, MI 49015 |
Contact | Feldman, M.s. |
Correspondent | Feldman, M.s. ANATECH, LTD. 1020 HARTS LAKE RD. Battle Creek, MI 49015 |
Product Code | IFP |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-08 |
Decision Date | 1987-08-06 |