The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Dual-aid.
Device ID | K860949 |
510k Number | K860949 |
Device Name: | DUAL-AID |
Classification | Airway, Oropharyngeal, Anesthesiology |
Applicant | VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
Contact | Lovina G Freeman |
Correspondent | Lovina G Freeman VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa, KS 66215 |
Product Code | CAE |
CFR Regulation Number | 868.5110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-12 |
Decision Date | 1986-05-06 |