Cleared Traditional

K770873 - CIRCUMCISION KIT
(FDA 510(k) Clearance)

K770873 · American Hospital Supply Corp. · Obstetrics & Gynecology
Jul 1977
Decision
59d
Days
Class 2
Risk

K770873 is an FDA 510(k) clearance for the CIRCUMCISION KIT, a Bell, Circumcision (Class II — Special Controls, product code FHG), submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977, 59 days after receiving the submission on May 13, 1977. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K770873 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1977
Decision Date July 11, 1977
Days to Decision 59 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code FHG — Bell, Circumcision
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530