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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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model #825 adult stim. pads polymer type Cardiotronics, Inc. k882337 08/02/1988
ats para-set carbol-xylene solution Alpha-Tech Systems, Inc. k883061 08/17/1988
qm300 rheumatoid factor antigen pack Kallestad Diag, A Div. of Erbamont, Inc. k883536 09/07/1988
bradbury intraocular retinal kit cat #200 Microline Pentax, Inc. k881049 09/12/1988
parker bathing system Mid-Canada Medical k883308 09/22/1988
bernsco electrosurgical shield Bernsco Surgical Supply, Inc. k883823 10/04/1988
wilson biomedical coronary guiding catheter Wilson Biomedical, Inc. k881793 10/19/1988
multiflow(tm) 60 kit Hospal Medical Corp. k884365 12/08/1988
uv air sterilight Allseasons Environmental Control, Inc. k884579 12/12/1988
slt clmd contact laser Surgical Laser Technologies, Inc. k884815 12/22/1988

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