White Cross Sterile Pad 4IN. X 4IN.

FDA 510(k) K854809 · American White Cross, Inc.

Substantially Equivalent

510(k) numberK854809

Submission

Device name
White Cross Sterile Pad 4IN. X 4IN.
Applicant
American White Cross, Inc.
New Rochelle, NY, US
Received
December 3, 1985
Decision date
January 13, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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K853558Dosimetric Release/Radiation Steriliz. Absorb Gauz · Traditional 09/05/1985SE
K853334Non-Adhera Adhesive Pad 3X4NAD · Traditional 08/21/1985SE
K852412Non-Adherent PadEFQ · Traditional 07/29/1985SE
K852408Extra Large Adhesive StripsKGX · Traditional 07/29/1985SE
K852462Tricot Adhesive BandageKGX · Traditional 07/26/1985SE
K8505953 X 4 Non-Adherent Pad · Traditional 03/11/1985SE

Questions and answers

When was White Cross Sterile Pad 4IN. X 4IN. cleared by the FDA?

White Cross Sterile Pad 4IN. X 4IN. (K854809) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 41 days after the submission was received.