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510(k) K910983

IV 1000 INSUFFLATOR RAPID FLOW by M.D. Engineering, Inc. — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
March 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

Other clearances by M.D. Engineering, Inc.

  • K912882 — INNERVISION LAPAROSCOPE AND ACCESSORIES (January 24, 1992)
  • K910982 — INNERVISION IRRIGATION PUMP (August 26, 1991)
  • K883384 — TS1000 SUCTION TIP (November 2, 1988)

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