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510(k) K943989

LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT by Gabris Surgical Corp. — Product Code HFO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 12, 1994
Date Received: August 16, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Recorder, Pressure, Intrauterine
Device Class: Class II
Regulation Number: 884.2700
Review Panel: OB
Submission Type

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K954774 — SHIELDED TROCAR (OBTURATOR) (June 7, 1996)
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K944104 — GABRIS LAPAROSCOPIC SURGICAL KITS (September 13, 1994)
K944103 — LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (September 12, 1994)
K930716 — LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION (July 23, 1993)