Cleared Traditional

HM-0660

K932782 · Hill-Med, Inc. · Obstetrics & Gynecology
Mar 1994
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K932782 is an FDA 510(k) clearance for the HM-0660, a Colposcope (and Colpomicroscope) (Class II — Special Controls, product code HEX), submitted by Hill-Med, Inc. (Miami, US). The FDA issued a Cleared decision on March 23, 1994, 287 days after receiving the submission on June 9, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1630.

Submission Details

510(k) Number K932782 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1993
Decision Date March 23, 1994
Days to Decision 287 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HEX — Colposcope (and Colpomicroscope)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1630

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