Cleared Traditional

ONCE TM

K800162 · G.D. Searle and Co. · Obstetrics & Gynecology
Feb 1980
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K800162 is an FDA 510(k) clearance for the ONCE TM, a Diaphragm, Contraceptive (and Accessories) (Class II — Special Controls, product code HDW), submitted by G.D. Searle and Co. (Walker, US). The FDA issued a Cleared decision on February 11, 1980, 17 days after receiving the submission on January 25, 1980. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5350.

Submission Details

510(k) Number K800162 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1980
Decision Date February 11, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HDW — Diaphragm, Contraceptive (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5350