The following data is part of a premarket notification filed by Medical Instruments And Lamps with the FDA for Effner-saling Laryngoscope For New-born.
Device ID | K844776 |
510k Number | K844776 |
Device Name: | EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN |
Classification | Laryngoscope, Rigid |
Applicant | MEDICAL INSTRUMENTS AND LAMPS P.O. BOX 1139 Port Washington, NY 11050 |
Contact | Emmanuel Anapliotis |
Correspondent | Emmanuel Anapliotis MEDICAL INSTRUMENTS AND LAMPS P.O. BOX 1139 Port Washington, NY 11050 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-10 |
Decision Date | 1985-10-01 |