1424 Tumistore

FDA 510(k) K822914 · Life-Tech Intl., Inc.

Substantially Equivalent

510(k) numberK822914

Submission

Device name
1424 Tumistore
Applicant
Life-Tech Intl., Inc.
Walker, MI, US
Received
October 1, 1982
Decision date
December 3, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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Questions and answers

When was 1424 Tumistore cleared by the FDA?

1424 Tumistore (K822914) received a 510(k) decision of Substantially Equivalent on December 3, 1982, 63 days after the submission was received.