The Stripper PGD

FDA 510(k) K041435 · Mid-Atlantic Diagnostics, Inc.

Substantially Equivalent

510(k) numberK041435

Submission

Device name
The Stripper PGD
Applicant
Mid-Atlantic Diagnostics, Inc.
Marlton, NJ, US
Received
May 28, 2004
Decision date
September 29, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
MQH – Microtools, Assisted Reproduction (Pipettes)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.6130
Specialty
Obstetrics/Gynecology

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Questions and answers

When was The Stripper PGD cleared by the FDA?

The Stripper PGD (K041435) received a 510(k) decision of Substantially Equivalent on September 29, 2004, 124 days after the submission was received.

What is the product code of K041435?

The FDA product code is MQH – Microtools, Assisted Reproduction (Pipettes), a Class II (moderate risk) device regulated under 21 CFR 884.6130.