The following data is part of a premarket notification filed by Cadema Medical Products, Inc. with the FDA for Aerosol Delivery System (aero-tech Ii).
Device ID | K873930 |
510k Number | K873930 |
Device Name: | AEROSOL DELIVERY SYSTEM (AERO-TECH II) |
Classification | Nebulizer (direct Patient Interface) |
Applicant | CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
Contact | Kathleen D Bordoni |
Correspondent | Kathleen D Bordoni CADEMA MEDICAL PRODUCTS, INC. P.O. BOX 250 Middletown, NY 10940 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-25 |
Decision Date | 1987-12-07 |