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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 K912023
Device Name LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR
Applicant
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Applicant Contact DONNA PAGE
Correspondent
Laserscope
3052 Orchard Dr.
San Jose,  CA  95134
Correspondent Contact DONNA PAGE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/07/1991
Decision Date 06/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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