The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Psi Surgical Aspirator.
Device ID | K832100 |
510k Number | K832100 |
Device Name: | PSI SURGICAL ASPIRATOR |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | ADVANCED BIOSEARCH ASSN. 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 | 1983-06-29 |
Decision Date | 1983-10-04 |