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510(k) K952759

TOWEL PACK by Medcare Custom Packaging, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1995
Date Received
June 16, 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 Medcare Custom Packaging, Inc.

  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)
  • K954442 — STERILE ISOTONIC SALINE & STERILE WATER (December 21, 1995)
  • K950390 — URETHRAL CATHETERIZATION TRAY (May 30, 1995)
  • K943661 — STERILE PHYSIOLOGICAL SALINE/STERILE WATER (April 10, 1995)
  • K951149 — SINGLE USE INSTRUMENT TRAY (April 6, 1995)
  • K934732 — PELVIC EXAM TRAY (December 30, 1994)
  • K942000 — BURN DRESSING TRAY (May 20, 1994)
  • K936261 — CATHETER INSERTION TRAY (March 10, 1994)
  • K922179 — CATHETER INSERTION TRAY (July 2, 1993)
  • K901856 — CUSTOM WOUND MANAGEMENT KITS AND TRAYS (August 1, 1990)

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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)