The following data is part of a premarket notification filed by Kolster Methods with the FDA for General Asperator.
| Device ID | K895761 |
| 510k Number | K895761 |
| Device Name: | GENERAL ASPERATOR |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | KOLSTER METHODS 1895 W. COMMONWEALTH AVE. UNIT 'G' Fullerton, CA 92633 |
| Contact | Alwin Kolster |
| Correspondent | Alwin Kolster KOLSTER METHODS 1895 W. COMMONWEALTH AVE. UNIT 'G' Fullerton, CA 92633 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851314007045 | K895761 | 000 |
| 00851314007038 | K895761 | 000 |
| 00851314007014 | K895761 | 000 |
| 00851314007007 | K895761 | 000 |