The following data is part of a premarket notification filed by Allergy Direct with the FDA for Event Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow Encasing, Event Bedding System.
| Device ID | K992702 |
| 510k Number | K992702 |
| Device Name: | EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | ALLERGY DIRECT 8800 EAST 63RD ST. Kansas City, MO 64133 |
| Contact | Gavin Mclaclan |
| Correspondent | Gavin Mclaclan ALLERGY DIRECT 8800 EAST 63RD ST. Kansas City, MO 64133 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-12 |
| Decision Date | 1999-11-08 |
| Summary: | summary |