The following data is part of a premarket notification filed by Anatech, Ltd. with the FDA for Nbf 10% Neutral Buffered Formalin.
Device ID | K870852 |
510k Number | K870852 |
Device Name: | NBF 10% NEUTRAL BUFFERED FORMALIN |
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 | 1987-03-03 |
Decision Date | 1987-03-31 |