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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K011755
Device Name STRYKER T4 HYTREL (R) TOGAS
Applicant
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact SUZANNE VELASQUEZ
Correspondent
Stryker Corp.
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact SUZANNE VELASQUEZ
Regulation Number878.4040
Classification Product Code
LYU  
Date Received06/06/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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