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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K827796
Device Name INNOSCAN EXAMINATION LIGHT
Applicant
Innomed Corp.
10 Rye Ridge Plz.
Rye Brook,  NY  10573
Correspondent
Innomed Corp.
10 Rye Ridge Plz.
Rye Brook,  NY  10573
Date Received07/29/1982
Decision Date 08/24/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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