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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K827379
Device Name X-RAY CASSETTE
Applicant
Synchroplan Corp.
32 W. 40th St.
New York,  NY  10018
Correspondent
Synchroplan Corp.
32 W. 40th St.
New York,  NY  10018
Date Received04/19/1982
Decision Date 05/19/1982
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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