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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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sunbed Sun Health Systems k842787 08/15/1984
summit optics post-mydriatic spectacles Summit Optics, Inc. k871800 06/11/1987
modified to modular fr severe bone loss trauma Sulzermedica k002324 08/24/2000
natural-knee ii system-durasul tibial insert and durasul all-poly patella Sulzer Orthopedics, Inc. k002335 10/25/2000
stryker navigation system-spine & fluoroscopy modules Stryker Instruments k003111 01/04/2001
stryker remote surgical planning system Stryker Instruments k004027 01/24/2001
stryker irrigation tube set Stryker Endoscopy k000493 05/15/2000
para-7 Streck Laboratories, Inc. k791227 08/03/1979
periograf Sterling Drug, Inc. k813070 11/20/1981
alkaline phosphatase reagent set Sterling Biochemical, Inc. k843332 09/14/1984

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