The following data is part of a premarket notification filed by Aeros Instruments, Inc. with the FDA for Aeros Aspirator.
Device ID | K952103 |
510k Number | K952103 |
Device Name: | AEROS ASPIRATOR |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | AEROS INSTRUMENTS, INC. 1111 LAKESIDE DR. Gurnee, IL 60031 |
Contact | Chris Gossett |
Correspondent | Chris Gossett AEROS INSTRUMENTS, INC. 1111 LAKESIDE DR. Gurnee, IL 60031 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-04 |
Decision Date | 1995-07-31 |