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510(k) K953548

LAPAROSCOPIC SURGICAL INSTRUMENT by Gabris Surgical Corp. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1995
Date Received
July 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

Other clearances by Gabris Surgical Corp.

  • K954774 — SHIELDED TROCAR (OBTURATOR) (June 7, 1996)
  • K944640 — LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT (October 11, 1994)
  • K944104 — GABRIS LAPAROSCOPIC SURGICAL KITS (September 13, 1994)
  • K944103 — LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (September 12, 1994)
  • K943989 — LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT (September 12, 1994)
  • K930716 — LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION (July 23, 1993)

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