Cleared Traditional

JARIT SURGICAL INSTRUMENTS

K932072 · Medical Device Inspection Co., Inc. · Obstetrics & Gynecology
Jan 1994
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K932072 is an FDA 510(k) clearance for the JARIT SURGICAL INSTRUMENTS, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on January 11, 1994, 258 days after receiving the submission on April 28, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.

Submission Details

510(k) Number K932072 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1993
Decision Date January 11, 1994
Days to Decision 258 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code HET — Laparoscope, Gynecologic (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1720

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