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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K960347
Device Name SAFETY TROCER WITH SPRINGLOADED OBDURATOR
Applicant
SPIESS DESIGN, INC.
290 TELSER RD.
LAKE ZURICH,  IL  60047
Applicant Contact DIETER KEPPEL
Correspondent
SPIESS DESIGN, INC.
290 TELSER RD.
LAKE ZURICH,  IL  60047
Correspondent Contact DIETER KEPPEL
Regulation Number884.1720
Classification Product Code
HET  
Date Received01/25/1996
Decision Date 07/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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