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510(k) K954703

MEDI-FRIG by Ellman Intl., Inc. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1996
Date Received
October 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

Other clearances by Ellman Intl., Inc.

  • K013255 — SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF (November 7, 2001)
  • K003126 — BIPOLAR TRIGGER-FLEX PROBE (April 11, 2001)
  • K001986 — SURGITRON IEC II (September 27, 2000)
  • K001407 — SURGITRON IEC II (July 24, 2000)
  • K001253 — SURGITRON IEC II (May 26, 2000)
  • K992382 — SURGITRON RADIOLASE (October 14, 1999)
  • K990146 — SURGITRON (March 17, 1999)
  • K980177 — SUGITRON MODEL: IEC (July 7, 1998)
  • K980170 — SURGITRON (June 29, 1998)
  • K972072 — SURGITRON MODEL FFPF-EMC (June 19, 1997)

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