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FDA 510(k) Application Details - K970968
Device Classification Name
Laparoscope, Gynecologic (And Accessories)
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510(K) Number
K970968
Device Name
Laparoscope, Gynecologic (And Accessories)
Applicant
GUENTER BISSINGER MEDIZINTECHNIK GMBH
GOTTLIEB-DAIMLER-STR. 5
(ROHRLACHE)
TENINGEN D-79331 DE
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Contact
DAVID W SCHLERF
Other 510(k) Applications for this Contact
Regulation Number
884.1720
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Classification Product Code
HET
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More FDA Info for this Product Code
Date Received
03/17/1997
Decision Date
05/21/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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