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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saw, Electrically Powered
510(k) Number K912237
Device Name STRYKER ECLIPSE WARMING STRETCHER
Applicant
Stryker Medical
6300 S. Sprinkle Rd.
Kalamazoo,  MI  49001
Applicant Contact DAVID JOHNSON
Correspondent
Stryker Medical
6300 S. Sprinkle Rd.
Kalamazoo,  MI  49001
Correspondent Contact DAVID JOHNSON
Regulation Number878.4820
Classification Product Code
DWI  
Date Received05/21/1991
Decision Date 07/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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