The following data is part of a premarket notification filed by Ipt Technologies, Inc. with the FDA for Ipt Capsule Mixer.
Device ID | K922203 |
510k Number | K922203 |
Device Name: | IPT CAPSULE MIXER |
Classification | Amalgamator, Dental, Ac-powered |
Applicant | IPT TECHNOLOGIES, INC. 2550 N. FEDERAL HIGHWAY FORT LAUDERDALE, FL 33305 |
Contact | INGOLF V JANERUS |
Correspondent | INGOLF V JANERUS IPT TECHNOLOGIES, INC. 2550 N. FEDERAL HIGHWAY FORT LAUDERDALE, FL 33305 |
Product Code | EFD |
CFR Regulation Number | 872.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-11 |
Decision Date | 1992-06-03 |