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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
510(k) Number K914177
Device Name HYDRODISECTOR
Applicant
Spiess Design, Inc.
495 Lindberg Ln.
Northbrook,  IL  60062
Applicant Contact JOACHIM SPIESS
Correspondent
Spiess Design, Inc.
495 Lindberg Ln.
Northbrook,  IL  60062
Correspondent Contact JOACHIM SPIESS
Regulation Number878.4780
Classification Product Code
JCX  
Date Received09/18/1991
Decision Date 11/29/1991
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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