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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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varicella/zoster virus Institute Virion , Ltd. k843676 09/26/1985
mic-concept system Microtech Medical Systems, Inc. k852613 09/20/1985
coagulation factor viii deficient substrate plasma American Dade k853462 08/29/1985
tubulitec primer Dental Therapeutics AB k851052 07/31/1985
chesebrough-pond's sequential wound dressing Chesebrough-Pond'S U.S.A. Co. k851382 07/05/1985
urotec/franklin soft simplastic catheter Urotec Systems Corp. k851684 07/02/1985
privatan home tanning center Privatan, Inc. k852290 06/21/1985
noninvasive electronic digital bp monitor ebm-1050 Unisonic Products Corp. k850476 04/29/1985
multi-size cassette holder Philips Medical Systems (Cleveland), Inc. k850125 03/26/1985
eosin methylene blue agar, ss agar, xld agar 6.5% Rapid City Regional Hospital, Inc. k850720 03/22/1985

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