The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Bronchodilator Tee - 9056 Series.
Device ID | K873521 |
510k Number | K873521 |
Device Name: | BRONCHODILATOR TEE - 9056 SERIES |
Classification | Nebulizer (direct Patient Interface) |
Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Contact | John R Boehringer |
Correspondent | John R Boehringer BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-01 |
Decision Date | 1988-03-02 |