The following data is part of a premarket notification filed by Tap Express, Inc. with the FDA for Tap Express Ejector.
Device ID | K941164 |
510k Number | K941164 |
Device Name: | TAP EXPRESS EJECTOR |
Classification | Evacuator, Oral Cavity |
Applicant | TAP EXPRESS, INC. 12300 S.W. 131 AVE. Miami, FL 33186 |
Contact | Claudio Nepi |
Correspondent | Claudio Nepi TAP EXPRESS, INC. 12300 S.W. 131 AVE. Miami, FL 33186 |
Product Code | EHZ |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-11 |
Decision Date | 1994-05-18 |