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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K894801
Device Name 30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
Applicant
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Applicant Contact THOMAS E COTTONE
Correspondent
Advance Medical Designs, Inc.
808 Pickens Industrial Dr.
Marietta,  GA  30062
Correspondent Contact THOMAS E COTTONE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/28/1989
Decision Date 09/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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