The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Devon Disposable Head Positioner Cover.
| Device ID | K894170 |
| 510k Number | K894170 |
| Device Name: | DEVON DISPOSABLE HEAD POSITIONER COVER |
| Classification | Bedding, Disposable, Medical |
| Applicant | DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
| Contact | Rudy Gaba |
| Correspondent | Rudy Gaba DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-15 |
| Decision Date | 1989-09-07 |