The following data is part of a premarket notification filed by Eare Consulting Service with the FDA for Lite-blade.
Device ID | K944428 |
510k Number | K944428 |
Device Name: | LITE-BLADE |
Classification | Laryngoscope, Rigid |
Applicant | EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
Contact | Emanuel A Rosen |
Correspondent | Emanuel A Rosen EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-12 |
Decision Date | 1994-11-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LITE-BLADE 74625192 not registered Dead/Abandoned |
TRUPHATEK INTERNATIONAL LIMITED 1995-01-24 |