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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K963775
Device Name MODEL 8800 ASPIRATOR
Applicant
Medical Specifics, Inc.
3306 Wiley Post Rd., Suite 106
Carrollton,  TX  75006
Applicant Contact HOWARD CHILTON
Correspondent
Medical Specifics, Inc.
3306 Wiley Post Rd., Suite 106
Carrollton,  TX  75006
Correspondent Contact HOWARD CHILTON
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/19/1996
Decision Date 03/26/1997
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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