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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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fluoricon 500 image intensifiers GENERAL ELECTRIC CO. k770094 01/21/1977
oral irrigator CLAIROL, INC. k770368 03/01/1977
aerosol t adapter, #752 SURGICOT, INC. k770585 04/05/1977
tray, irrigation, sterile, basic LUKENS CORP. k770799 06/22/1977
flexion mittens STAT MEDICAL CORP. k771030 06/27/1977
cryosurgical equipment A.S.M.O.T. k771320 12/06/1977
will-ceram w-3 WILLIAMS GOLD REFINING CO., INC. k771596 08/26/1977
creatinine GAMMA ENTERPRISES, INC. k771834 11/03/1977
hearing aid-model pe-1 STARKEY LABORATORIES, INC. k772101 11/21/1977
pregnancy test kit, answer DIAGNOSTIC TESTING, INC. k772359 01/05/1978

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