Submission Details
| 510(k) Number | K893452 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1989 |
| Decision Date | June 22, 1989 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
K893452 is an FDA 510(k) clearance for the EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM, a Table, Radiographic, Non-tilting, Powered (Class II — Special Controls, product code IZZ), submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on June 22, 1989, 50 days after receiving the submission on May 3, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K893452 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1989 |
| Decision Date | June 22, 1989 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZZ — Table, Radiographic, Non-tilting, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1980 |