Vapocide

FDA 510(k) K970726 · Cottrell, Ltd.

Substantially Equivalent

510(k) numberK970726

Submission

Device name
Vapocide
Applicant
Cottrell, Ltd.
North Attleboro, MA, US
Received
February 28, 1997
Decision date
May 18, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MED – Sterilant, Medical Devices
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6885
Specialty
General Hospital

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Questions and answers

When was Vapocide cleared by the FDA?

Vapocide (K970726) received a 510(k) decision of Substantially Equivalent on May 18, 1998, 444 days after the submission was received.

What is the product code of K970726?

The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.