Cleared Traditional

SPERM SELECT SYSTEM

K900308 · Pharmacia, Inc. · Obstetrics & Gynecology
Apr 1990
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K900308 is an FDA 510(k) clearance for the SPERM SELECT SYSTEM, a Cap, Cervical (Class II — Special Controls, product code HDR), submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on April 13, 1990, 81 days after receiving the submission on January 22, 1990. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.

Submission Details

510(k) Number K900308 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1990
Decision Date April 13, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HDR — Cap, Cervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5250