The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Electric Motor W/physio Dispenser, Handpieces.
Device ID | K900178 |
510k Number | K900178 |
Device Name: | ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES |
Classification | Unit, Oral Irrigation |
Applicant | CORE-VENT CORP. 15821 VENTURA BLVD. Encino, CA 91436 |
Contact | Patrick, Dds |
Correspondent | Patrick, Dds CORE-VENT CORP. 15821 VENTURA BLVD. Encino, CA 91436 |
Product Code | EFS |
CFR Regulation Number | 872.6510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-16 |
Decision Date | 1990-05-31 |