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510(k) K921568

ORS-100 by Mnlase, Inc. — Product Code JRM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1992
Date Received
April 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Freezer
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Mnlase, Inc.

  • K944630 — MODEL 230-SAS LASER DELIVERY PROBE (November 9, 1994)
  • K944629 — MODEL 230-SAC LASER DELIVERY PROBE (November 3, 1994)
  • K944471 — STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE (November 3, 1994)
  • K944628 — MODEL 220-SS LASER DELIVERY PROBE (November 3, 1994)
  • K944470 — CURVED ENDOPHOTOCOAGULATOR LASER PROBE (November 3, 1994)
  • K944627 — MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER (November 3, 1994)
  • K944625 — MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER (November 3, 1994)
  • K944626 — MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER (November 3, 1994)
  • K944622 — MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER (November 1, 1994)
  • K944623 — MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER (November 1, 1994)

Other clearances for product code JRM

  • K921570 — ORS-300 (June 9, 1992)
  • K921569 — ORS-200 (June 9, 1992)
  • K915427 — ORS-1000 (January 7, 1992)
  • K913777 — SELF-CONTAINED SURGICAL SLUSH FREEZER (September 25, 1991)
  • K894006 — SANISERV SURGICAL SLUSH SYSTEM (November 3, 1989)
  • K782077 — LANCER ICE CUBE (April 3, 1979)