Submission Details
| 510(k) Number | K980509 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 10, 1998 |
| Decision Date | February 26, 1998 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
Feb 1998
Decision
16d
Days
Class 1
Risk
About This 510(k) Submission
K980509 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS, a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on February 26, 1998, 16 days after receiving the submission on February 10, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.
Device Classification
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5710 |
Manufacturer
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