The following data is part of a premarket notification filed by Microwave Medical, Inc. with the FDA for Microwave Delivery System, Model Mmc-300.
Device ID | K991456 |
510k Number | K991456 |
Device Name: | MICROWAVE DELIVERY SYSTEM, MODEL MMC-300 |
Classification | System, Microwave, Hair Removal |
Applicant | MICROWAVE MEDICAL, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
Contact | Greg Holland |
Correspondent | Greg Holland MICROWAVE MEDICAL, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
Product Code | MWY |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-26 |
Decision Date | 1999-10-25 |