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510(k) K052243

PROACT WITH GEL OR PROACT 1 by Proact, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2006
Date Received
August 17, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Proact, Inc.

  • K003909 — PROACT 1 (June 13, 2001)
  • K941256 — QUICK CORE II (July 13, 1994)
  • K926559 — PROACT BIOPSY NEEDLE ENCHANCEMENTS (March 22, 1993)
  • K913306 — BONE-TEMNO/STERNUM-TEMNO (November 1, 1991)
  • K902320 — BAUER FLEXI-TEMNO BIOPSY NEEDLE (October 1, 1990)
  • K902319 — BAUER TEMNO BIOPSY NEEDLE (September 6, 1990)

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