The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Bauman Disposable Laryngoscope Blades.
Device ID | K905273 |
510k Number | K905273 |
Device Name: | BAUMAN DISPOSABLE LARYNGOSCOPE BLADES |
Classification | Laryngoscope, Rigid |
Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Contact | Alberto Velez |
Correspondent | Alberto Velez VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Product Code | CCW |
CFR Regulation Number | 868.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-23 |
Decision Date | 1992-03-24 |