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510(k) K950830

STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP by Avail-Southwest Division — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
February 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Avail-Southwest Division

  • K952678 — STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (July 10, 1995)
  • K933520 — ENDOSCOPIC ANTI-FOG KIT, 100-302-00 (August 24, 1993)
  • K864158 — THERMAPAD (March 2, 1987)

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