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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K935949
Device Name STRYKER 5000
Applicant
Stryker Medical
6300 S. Sprinkle Rd.
Kalamazoo,  MI  49001
Applicant Contact CHAD COBERLY
Correspondent
Stryker Medical
6300 S. Sprinkle Rd.
Kalamazoo,  MI  49001
Correspondent Contact CHAD COBERLY
Regulation Number880.5550
Classification Product Code
FNM  
Date Received12/13/1993
Decision Date 06/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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