Cleared Traditional

K831669 - AXCAN SPERM CUP
(FDA 510(k) Clearance)

K831669 · Axcan Scientific Corp. · Obstetrics & Gynecology

Jul 1983

Decision

50d

Days

Class 2

Risk

K831669 is an FDA 510(k) clearance for the AXCAN SPERM CUP. This device is classified as a Cap, Cervical (Class II — Special Controls, product code HDR).

Submitted by Axcan Scientific Corp. (Walker, US). The FDA issued a Cleared decision on July 12, 1983, 50 days after receiving the submission on May 23, 1983.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number	K831669 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1983
Decision Date	July 12, 1983
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—