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510(k) K954824

PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE by Medical Creative Technologies, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1996
Date Received
October 20, 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 Medical Creative Technologies, Inc.

  • K973259 — K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) (September 10, 1997)
  • K962147 — DEXTERITY PNEUMO SLEEVE SET (July 9, 1996)

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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)