Submission Details
| 510(k) Number | K901928 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 1990 |
| Decision Date | July 26, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
K901928 is an FDA 510(k) clearance for the INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Interpore Intl. (Rockville, US). The FDA issued a Cleared decision on July 26, 1990, 90 days after receiving the submission on April 27, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.
| 510(k) Number | K901928 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 1990 |
| Decision Date | July 26, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EGG — Attachment, Precision, All |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.3165 |