The following data is part of a premarket notification filed by Medical Consultants Intl. Ltd. with the FDA for Medi Model Sbl502-b (liss Body Stimulator) Zero Dc.
Device ID | K902976 |
510k Number | K902976 |
Device Name: | MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC |
Classification | Electrode, Depth |
Applicant | MEDICAL CONSULTANTS INTL. LTD. 59 OXFORD PLACE Glen Rock, NJ 07452 |
Contact | Saul Liss |
Correspondent | Saul Liss MEDICAL CONSULTANTS INTL. LTD. 59 OXFORD PLACE Glen Rock, NJ 07452 |
Product Code | GZL |
CFR Regulation Number | 882.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-06 |
Decision Date | 1990-09-07 |