Submission Details
| 510(k) Number | K970930 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 1997 |
| Decision Date | April 23, 1997 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE
Apr 1997
Decision
41d
Days
Class 1
Risk
About This 510(k) Submission
K970930 is an FDA 510(k) clearance for the BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE, a Retainer, Screw Expansion, Orthodontic (Class I — General Controls, product code DYJ), submitted by Cleft Palate Appliances, Inc. (London, CA). The FDA issued a Cleared decision on April 23, 1997, 41 days after receiving the submission on March 13, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.
Device Classification
| Product Code | DYJ — Retainer, Screw Expansion, Orthodontic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.5410 |
Manufacturer
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