Submission Details
| 510(k) Number | K953470 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 1995 |
| Decision Date | November 21, 1995 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
Cleared
Traditional
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
Nov 1995
Decision
120d
Days
Class 1
Risk
About This 510(k) Submission
K953470 is an FDA 510(k) clearance for the FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS), a Pad, Menstrual, Unscented (Class I — General Controls, product code HHD), submitted by Mediquip, Inc. (Arlington, US). The FDA issued a Cleared decision on November 21, 1995, 120 days after receiving the submission on July 24, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5435.
Device Classification
| Product Code | HHD — Pad, Menstrual, Unscented |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 884.5435 |
| Definition | An Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic And Synthetic Material With An Established Safety Profile. |
Manufacturer
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