The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Industries, Inc. Infant Transport Mattress.
| Device ID | K980509 |
| 510k Number | K980509 |
| Device Name: | DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Camille Matlock |
| Correspondent | Camille Matlock DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-10 |
| Decision Date | 1998-02-26 |
| Summary: | summary |