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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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plain and chronic gut absorbable surgical sutures, usp ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. k000542 04/28/2000
plasma sprayed shoulder ENCORE ORTHOPEDICS, INC. k003324 12/06/2001
pocket ultrasonic ophthalmic pachymeter, biometry transducer for pocket QUANTEL MEDICAL k000554 03/14/2000
polymer coated, powder-free latex examination glove with protein labelling claim, contains 50 micrograms or less of tota PERUSAHAAN GETAH ASAS SDN BHD k001529 06/12/2000
porocoat prodigy hip prosthesis DEPUY ORTHOPAEDICS, INC. k001778 07/07/2000
positube PARAPRODUCTS, INC. k000045 03/15/2000
powder free latex examination gloves with water extractable protein labeling claim. (50 micrograms or less) ALLIANCE RUBBER PRODUCTS SDN. BHD. k002701 09/13/2000
powder-free latex examination gloves with protein content labeling claim (50 micrograms or less) SHASTA ASIA PARTNERS GLOVES MANUFACTURING CO LTD. k000584 04/12/2000
powerdrive 350 option PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. k002415 08/18/2000
pq1 ULTRADENT PRODUCTS, INC. k000189 05/11/2000

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