The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Surgi Squeez.
Device ID | K894927 |
510k Number | K894927 |
Device Name: | SURGI SQUEEZ |
Classification | Infusor, Pressure, For I.v. Bags |
Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
Contact | John Young |
Correspondent | John Young ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
Product Code | KZD |
CFR Regulation Number | 880.5420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-02 |
Decision Date | 1989-09-11 |