K973447 is an FDA 510(k) clearance for the OMNIFLATOR 6630(6-630-00). This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on September 30, 1998, 384 days after receiving the submission on September 11, 1997.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K973447 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 1997 |
| Decision Date | September 30, 1998 |
| Days to Decision | 384 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |