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510(k) K003909

PROACT 1 by Proact Co. — Product Code IRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2001
Date Received
December 19, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Powered Inflatable Tube
Device Class
Class II
Regulation Number
890.5650
Review Panel
PM
Submission Type

Other clearances by Proact Co.

  • K052243 — PROACT WITH GEL OR PROACT 1 (April 12, 2006)
  • 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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