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510(k) K955011

CANDELA HCS 2000 URETHERAL WARMER CATHETER by Candela Laser Corp. — Product Code GEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1996
Date Received
November 1, 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

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  • K953412 — CANDELA MODEL PLTL-1 LASER SYSTEM (October 24, 1995)
  • K953294 — CANDELA CRYOSYSTEM CS-5 (October 18, 1995)
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  • K946386 — CANDELA RUBY LAZE Q-SWITCHED RUBY LASER (March 24, 1995)
  • K950661 — CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE (March 10, 1995)
  • K943292 — CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS (March 9, 1995)

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