K902830 is an FDA 510(k) clearance for the PERI-BOTTLE. This device is classified as a Douche Apparatus, Vaginal, Therapeutic (Class I - General Controls, product code HED).
Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on August 6, 1990, 39 days after receiving the submission on June 28, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5900.
| 510(k) Number | K902830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 1990 |
| Decision Date | August 06, 1990 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HED — Douche Apparatus, Vaginal, Therapeutic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.5900 |