Correct-A-Count

FDA 510(k) K853374 · Dermacare Products, Inc.

Substantially Equivalent

510(k) numberK853374

Submission

Device name
Correct-A-Count
Applicant
Dermacare Products, Inc.
Louisville, KT, US
Received
August 12, 1985
Decision date
September 5, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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K871910Surgitek Disposable Bipolar CordGEI · Traditional 06/01/1987SE
K863280DermamarkerFZZ · Traditional 09/09/1986SE
K863279Surgi-Tek Tube Positioner · Traditional 09/09/1986SE
K863278Surgi-Wipes · Traditional 09/02/1986SE
K862367Pro-Clean · Traditional 07/08/1986SE

Questions and answers

When was Correct-A-Count cleared by the FDA?

Correct-A-Count (K853374) received a 510(k) decision of Substantially Equivalent on September 5, 1985, 24 days after the submission was received.