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510(k) K911953

MEDI GUARD SHEETS/UNDERLAYS by Sancella, Inc. — Product Code KME

K911953 is an FDA 510(k) premarket notification submitted by Sancella, Inc. for the device "MEDI GUARD SHEETS/UNDERLAYS". The FDA issued a decision of Substantially Equivalent on May 28, 1991. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Sancella, Inc. has at least 4 other 510(k) clearances on record.

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)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (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)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)
  • K911950 — MEDI GUARD DRAPES (May 21, 1991)

FDA data resources