The following data is part of a premarket notification filed by Anatech, Ltd. with the FDA for Xylene.
Device ID | K881282 |
510k Number | K881282 |
Device Name: | XYLENE |
Classification | Agent, Clearing |
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 | KEM |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-25 |
Decision Date | 1988-04-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XYLENE 72238302 0817628 Dead/Expired |
SANDOZ, INC. 1966-02-07 |