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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Cystometric, Electric
510(k) Number K942445
Device Name SYNERGY II
Applicant
Synectics Medical, Inc.
1425 Greenway Dr., #600
Irving,  TX  75038
Applicant Contact DAVID WOODRUFF
Correspondent
Synectics Medical, Inc.
1425 Greenway Dr., #600
Irving,  TX  75038
Correspondent Contact DAVID WOODRUFF
Regulation Number876.4890
Classification Product Code
MMZ  
Date Received05/23/1994
Decision Date 11/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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