K813335 is an FDA 510(k) clearance for the PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY. This device is classified as a Tray, Surgical, Needle (Class I - General Controls, product code FSH).
Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on January 8, 1982, 45 days after receiving the submission on November 24, 1981.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K813335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1981 |
| Decision Date | January 08, 1982 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FSH — Tray, Surgical, Needle |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |