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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K962147
Device Name DEXTERITY PNEUMO SLEEVE SET
Applicant
Medical Creative Technologies, Inc.
2950-N Advance Ln.
Colmar,  PA  18915 -9727
Applicant Contact PERK CROOK
Correspondent
Medical Creative Technologies, Inc.
2950-N Advance Ln.
Colmar,  PA  18915 -9727
Correspondent Contact PERK CROOK
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/03/1996
Decision Date 07/09/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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