K874615 is an FDA 510(k) clearance for the LASER CANNISTER FILTER. This device is classified as a Laser, Surgical, Gynecologic (Class II — Special Controls, product code HHR).
Submitted by Medical Marketing, Inc. (Fischer, US). The FDA issued a Cleared decision on June 23, 1988, 227 days after receiving the submission on November 9, 1987.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K874615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1987 |
| Decision Date | June 23, 1988 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHR — Laser, Surgical, Gynecologic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4550 |