The following data is part of a premarket notification filed by Storz Instrument Co. with the FDA for Storz Aspiration Machine Sam 5000.
| Device ID | K843644 |
| 510k Number | K843644 |
| Device Name: | STORZ ASPIRATION MACHINE SAM 5000 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Contact | Niles Ross |
| Correspondent | Niles Ross STORZ INSTRUMENT CO. 3365 TREE CT. INDUSTRIAL BLVD. St. Louis, MO 63122 -6694 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1984-11-16 |