Submission Details
| 510(k) Number | K963466 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 03, 1996 |
| Decision Date | February 13, 1997 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
PEDIATRIC LIMB HOLDER
Feb 1997
Decision
163d
Days
Class 1
Risk
About This 510(k) Submission
K963466 is an FDA 510(k) clearance for the PEDIATRIC LIMB HOLDER, a Restraint, Protective (Class I — General Controls, product code FMQ), submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on February 13, 1997, 163 days after receiving the submission on September 3, 1996. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6760.
Device Classification
| Product Code | FMQ — Restraint, Protective |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6760 |
Manufacturer
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