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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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510(K)
Number
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Decision
Date
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charles pneumatic intraocular scissors COOPER MEDICAL DEVICES CORP. k801850 09/16/1980
profile swab cat.#5273 & 5274 POLLAK (INTL.), LTD. k802004 09/16/1980
biometric systolic time interval system BIOMETRIC ANALYSIS GROUP, INC. k802198 09/26/1980
biological indicator - kemmed & biosure KEM MEDICAL PRODUCTS CORP. k802228 12/09/1980
gambro lundia plate disp. dialyzer GAMBRO, INC. k802389 12/22/1980
perm. endocardial unipolar wedge urethan DAIG CORP. k802553 01/16/1981
blended bifocal ROBINSON-HOUCHIN, INC. k802749 12/17/1980
respiratory syncytial virus antigen & ORION DIAGNOSTICA, INC. k802936 12/31/1980
mentor 150 transcutaneous nerve stimula GEORGE H. FRISCH k803121 12/30/1980
cold/hot pack W.G. WHITNEY CORP. k803299 01/15/1981

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