The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Gomco Suction Pump Cabinet Change.
Device ID | K810490 |
510k Number | K810490 |
Device Name: | GOMCO SUCTION PUMP CABINET CHANGE |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-24 |
Decision Date | 1981-03-13 |