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510(k) K974647

FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 by Customed, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1998
Date Received
December 12, 1997
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 Customed, Inc.

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  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K962596 — CUSTOMED BLOOD EXTRACTION KIT (September 27, 1996)
  • K961442 — UNIVERSAL DRAINAGE TRAY (May 9, 1996)
  • K953678 — STERIMED STERIZATION WRAPPER (NON-STERILE) (October 2, 1995)
  • K950295 — WOUND CLOSURE/LACERATION TRAY (April 18, 1995)
  • K942177 — FOLEY CATHETERIZATION TRAY (September 8, 1994)
  • K925017 — IV PREP KIT (NON-STERILE) (August 27, 1993)
  • K925018 — IV PREP KIT W/O DRESSING (NON-STERILE) (August 27, 1993)

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