The following data is part of a premarket notification filed by Med Labs, Inc. with the FDA for Mlt-2.
Device ID | K935981 |
510k Number | K935981 |
Device Name: | MLT-2 |
Classification | System, Communication, Powered |
Applicant | MED LABS, INC. 28 VEREDA CORDILLERA Goleta, CA 93117 |
Contact | Philip D Norvell |
Correspondent | Philip D Norvell MED LABS, INC. 28 VEREDA CORDILLERA Goleta, CA 93117 |
Product Code | ILQ |
CFR Regulation Number | 890.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-14 |
Decision Date | 1994-02-17 |