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510(k) K873313

SURGICAL DRAPE by American Medical Technology, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1987
Date Received
August 17, 1987
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 American Medical Technology, Inc.

  • K963808 — CHOICE POWERED WHEELCHAIR (February 12, 1997)
  • K905745 — AMETEC MASY MODULAR ANGIOSCOPE SYSTEM (April 23, 1992)
  • K874567 — RESUSCITATOR (February 29, 1988)
  • K874430 — NEEDLE CONTAINER (January 4, 1988)
  • K874360 — PLASTIC TUBING CONNECTOR (November 17, 1987)

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  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)