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510(k) K944567

COWBOY X by Kinetic Concepts, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
September 19, 1994
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

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  • K032310 — MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (October 10, 2003)
  • K022011 — V.A.C. ABDOMINAL DRESSING (February 26, 2003)
  • K021500 — VACUUM ASSISTED CLOSURE (December 20, 2002)
  • K021501 — V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT (December 2, 2002)
  • K020781 — WET CHAMBER (May 6, 2002)
  • K992448 — V.A.C. PLUS (January 18, 2000)
  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K972549 — SIMPULSE (November 18, 1997)

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