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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 K972178
Device Name UNISURGE INTERFACE P
Applicant
Unisurge Holding, Inc.
6107 Oakbrook Pkwy., Suite A
Norcross,  GA  30093 -1716
Applicant Contact STACIE BUTTORFF
Correspondent
Unisurge Holding, Inc.
6107 Oakbrook Pkwy., Suite A
Norcross,  GA  30093 -1716
Correspondent Contact STACIE BUTTORFF
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/10/1997
Decision Date 09/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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