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510(k) K912765

STASIS BUTTON PRSSURE DEVICE by Arch Development Group — Product Code MHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1991
Date Received
June 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Compression
Device Class
Class I
Regulation Number
880.5075
Review Panel
SU
Submission Type

Other clearances by Arch Development Group

  • K913047 — STERILESERT(TM) CABLE AND POLE DRAPE (October 2, 1991)

Other clearances for product code MHW

  • K070457 — SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB (May 16, 2007)