Submission Details
| 510(k) Number | K872906 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 1987 |
| Decision Date | August 11, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
K872906 is an FDA 510(k) clearance for the SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE, a Cannula, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEA), submitted by American Silk Sutures, Inc. (Lynn, US). The FDA issued a Cleared decision on August 11, 1987, 18 days after receiving the submission on July 24, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K872906 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 1987 |
| Decision Date | August 11, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GEA — Cannula, Surgical, General & Plastic Surgery |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |