The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Illuminator.
Device ID | K954787 |
510k Number | K954787 |
Device Name: | ILLUMINATOR |
Classification | Laryngoscope, Rigid |
Applicant | HOSPITAK, INC. 10 DANIEL ST. Farmingdale, NY 11735 |
Contact | William Laccy |
Correspondent | William Laccy HOSPITAK, INC. 10 DANIEL ST. Farmingdale, NY 11735 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-18 |
Decision Date | 1996-01-31 |