The following data is part of a premarket notification filed by Aeolus International Corporation with the FDA for Sniff Position Pillows/popitz Pillows.
| Device ID | K023010 |
| 510k Number | K023010 |
| Device Name: | SNIFF POSITION PILLOWS/POPITZ PILLOWS |
| Classification | Pillow, Cervical (for Mild Sleep Apnea) |
| Applicant | AEOLUS INTERNATIONAL CORPORATION 64 INDIAN COVE RD. Marion, MA 02738 -2113 |
| Contact | Michael D Popitz |
| Correspondent | Michael D Popitz AEOLUS INTERNATIONAL CORPORATION 64 INDIAN COVE RD. Marion, MA 02738 -2113 |
| Product Code | MYB |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-09 |
| Decision Date | 2002-10-01 |