Submission Details
| 510(k) Number | K872076 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 29, 1987 |
| Decision Date | June 15, 1987 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
K872076 is an FDA 510(k) clearance for the CORNING DISPOSABLE ROLLER BOTTLES, a Apparatus, Roller (Class I — General Controls, product code KJB), submitted by Corning Medical & Scientific (Oneonta, US). The FDA issued a Cleared decision on June 15, 1987, 17 days after receiving the submission on May 29, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.
| 510(k) Number | K872076 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 29, 1987 |
| Decision Date | June 15, 1987 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KJB — Apparatus, Roller |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.2240 |