The following data is part of a premarket notification filed by Amcor, Ltd. with the FDA for Slant/fin Hepa Clear.
| Device ID | K953536 |
| 510k Number | K953536 |
| Device Name: | SLANT/FIN HEPA CLEAR |
| Classification | Cleaner, Air, Medical Recirculating |
| Applicant | AMCOR, LTD. 5-39 46TH AVE. Long Island City, NY 11101 |
| Contact | Benjamin Levy |
| Correspondent | Benjamin Levy AMCOR, LTD. 5-39 46TH AVE. Long Island City, NY 11101 |
| Product Code | FRF |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-27 |
| Decision Date | 1995-10-30 |