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510(k) K964222

ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING by Paladin Medical, Inc. — Product Code LYL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1996
Date Received
October 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Solution, Ultrasonic Cleaners For Lenses
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

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  • K915743 — SHARPE ENDOTENACULUM (May 20, 1993)
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  • K915749 — SHARPE ENDOLIGATURE CARRIER (October 20, 1992)
  • K915744 — SHARPE ENDOHEMOSTAT (October 20, 1992)

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  • K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT (December 16, 2002)
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  • K020802 — RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (May 31, 2002)
  • K994021 — CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (February 22, 2000)
  • K991965 — PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (October 1, 1999)
  • K982115 — LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY (January 13, 1999)
  • K974724 — SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS (March 2, 1998)