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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 K935071
Device Name INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
1201 ROBERTS BLVD.
KENNESAW,  GA  30144
Applicant Contact PAUL L SUMNER
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
1201 ROBERTS BLVD.
KENNESAW,  GA  30144
Correspondent Contact PAUL L SUMNER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/25/1993
Decision Date 04/25/1994
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
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