K873097 is an FDA 510(k) clearance for the PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS. This device is classified as a Catheter, Continuous Irrigation (Class I - General Controls, product code GBQ).
Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on September 4, 1987, 39 days after receiving the submission on July 27, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K873097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 1987 |
| Decision Date | September 04, 1987 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GBQ — Catheter, Continuous Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |