Cotton Swabs

FDA 510(k) K820962 · Dafoe & Dafoe, Inc.

Substantially Equivalent

510(k) numberK820962

Submission

Device name
Cotton Swabs
Applicant
Dafoe & Dafoe, Inc.
Walker, MI, US
Received
April 6, 1982
Decision date
April 20, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KXF – Applicator, Absorbent Tipped, Non-Sterile
Device class
Class I (low risk)
Regulation
21 CFR 880.6025
Specialty
General Hospital

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Questions and answers

When was Cotton Swabs cleared by the FDA?

Cotton Swabs (K820962) received a 510(k) decision of Substantially Equivalent on April 20, 1982, 14 days after the submission was received.

What is the product code of K820962?

The FDA product code is KXF – Applicator, Absorbent Tipped, Non-Sterile, a Class I (low risk) device regulated under 21 CFR 880.6025.