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510(k) K092421

ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC by Gimmi GmbH — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2010
Date Received
August 7, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Gimmi GmbH

  • K093125 — ALPHAXENON LIGHT 180 W AND 300 W (January 27, 2010)
  • K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (May 6, 2009)
  • K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S. (March 11, 2002)
  • K012660 — GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES (December 20, 2001)
  • K013731 — GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BR (November 27, 2001)

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