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510(k) K911948

MEDI GUARD PILLOWCASE by Sancella, Inc. — Product Code KME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1991
Date Received
May 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
Review Panel
HO
Submission Type

Other clearances by Sancella, Inc.

  • K911944 — MEDI GUARD DENTAL BIB (October 4, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911950 — MEDI GUARD DRAPES (May 21, 1991)

Other clearances for product code KME

  • K042145 — READY-HEAT BLANKET (September 17, 2004)
  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)
  • K911950 — MEDI GUARD DRAPES (May 21, 1991)