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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 K893842
Device Name CYSTO APRONS IN VARIOUS SIZES
Applicant
Bemiss Jason Corp.
2319 E. Erwin
Tyler,  TX  75702
Applicant Contact F. R ZARTLER
Correspondent
Bemiss Jason Corp.
2319 E. Erwin
Tyler,  TX  75702
Correspondent Contact F. R ZARTLER
Regulation Number878.4040
Classification Product Code
LYU  
Date Received05/24/1989
Decision Date 08/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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