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510(k) K932449

DR. FOG by O.R. Concepts, Inc. — Product Code OCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1993
Date Received
May 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti Fog Solution And Accessories, Endoscopy
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Other clearances by O.R. Concepts, Inc.

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  • K935971 — FLOWGUN ELECTROCAUTERY PROBES (May 16, 1994)
  • K935645 — FLOWGUN REUSABLE IRRIGATION PROBES (March 7, 1994)
  • K926242 — ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE (October 15, 1993)
  • K922197 — INSUFFLATOR TUBING KIT (September 24, 1993)
  • K922244 — INSUFFLATOR TUBING/FILTER KIT (September 24, 1993)
  • K925147 — ORC 10.0MM SUCTION PROBE (June 25, 1993)
  • K925024 — ORC TAPPERED IRRIGATING PROBE (May 21, 1993)
  • K923908 — # 9455 AND #9457 POOLE TIP SUCTION PROBE (May 17, 1993)

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