The following data is part of a premarket notification filed by Interactive Consulting, Inc. with the FDA for Acta Oem Module.
Device ID | K972006 |
510k Number | K972006 |
Device Name: | ACTA OEM MODULE |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | INTERACTIVE CONSULTING, INC. 70 Walnut Street Wellesley, MA 02481 |
Contact | Jackie Masse |
Correspondent | Jackie Masse INTERACTIVE CONSULTING, INC. 70 Walnut Street Wellesley, MA 02481 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-30 |
Decision Date | 1997-07-10 |
Summary: | summary |