The following data is part of a premarket notification filed by Medical Consultants Intl. Ltd. with the FDA for Medi Liss Dental Analgesia Device (sbl601).
Device ID | K900731 |
510k Number | K900731 |
Device Name: | MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) |
Classification | Device, Electrical Dental Anesthesia |
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 | LWM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-15 |
Decision Date | 1990-12-17 |