Smart Klamp Various by Size

FDA 510(k) K032091 · Emergogroup, Inc.

Substantially Equivalent

510(k) numberK032091

Submission

Device name
Smart Klamp Various by Size
Applicant
Emergogroup, Inc.
Clearwater, FL, US
Received
July 7, 2003
Decision date
March 8, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HFX – Clamp, Circumcision
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

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Questions and answers

When was Smart Klamp Various by Size cleared by the FDA?

Smart Klamp Various by Size (K032091) received a 510(k) decision of Substantially Equivalent on March 8, 2004, 245 days after the submission was received.

What is the product code of K032091?

The FDA product code is HFX – Clamp, Circumcision, a Class II (moderate risk) device regulated under 21 CFR 884.4530.