Jarit Surgical Instruments

FDA 510(k) K932072 · Medical Device Inspection Co., Inc.

Substantially Equivalent

510(k) numberK932072

Submission

Device name
Jarit Surgical Instruments
Applicant
Medical Device Inspection Co., Inc.
Great Neck, NY, US
Received
April 28, 1993
Decision date
January 11, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HET – Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Specialty
Obstetrics/Gynecology

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Questions and answers

When was Jarit Surgical Instruments cleared by the FDA?

Jarit Surgical Instruments (K932072) received a 510(k) decision of Substantially Equivalent on January 11, 1994, 258 days after the submission was received.

What is the product code of K932072?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.