The following data is part of a premarket notification filed by Effner And Spreine Co. with the FDA for Effner Fe-ex* Orogastric.
Device ID | K874755 |
510k Number | K874755 |
Device Name: | EFFNER FE-EX* OROGASTRIC |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | EFFNER AND SPREINE CO. P.O. BOX 191 Port Washington, NY 11050 |
Contact | Emmanuel Anapliotis |
Correspondent | Emmanuel Anapliotis EFFNER AND SPREINE CO. P.O. BOX 191 Port Washington, NY 11050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-18 |
Decision Date | 1988-04-06 |