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510(k) K925659

U.C.E.Z. LENS CLEANER KIT by Anago, Inc. — Product Code OCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1993
Date Received
October 7, 1992
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 Anago, Inc.

  • K930161 — ANAGO SPINAL ANESTHESIA TRAY (July 6, 1993)
  • K926137 — ANAGO FEM-COOL/FEM-COOL PETITE (May 26, 1993)
  • K926589 — ANAGO WARM PACK (May 26, 1993)
  • K926590 — ANAGO DISPOSABLE INSTANT COLD PACK (May 26, 1993)
  • K920615 — ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT (March 20, 1993)
  • K915415 — GUARDALL SHIELD (October 15, 1992)
  • K913558 — RELIABLE CONE STYLE FACE MASK (November 7, 1991)
  • K905865 — ANTI-FOR SURGICAL FACE MASK (March 6, 1991)
  • K905749 — SURGICAL FACE MASK (March 4, 1991)
  • K904276 — DISPOSABLE BEARD COVER (November 21, 1990)

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