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510(k) K922143

AMERICAN BURN SHEET by American Silk Sutures, Inc. — Product Code KME

K922143 is an FDA 510(k) premarket notification submitted by American Silk Sutures, Inc. for the device "AMERICAN BURN SHEET". The FDA issued a decision of Substantially Equivalent on August 10, 1992. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. American Silk Sutures, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1992
Date Received
May 6, 1992
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 American Silk Sutures, Inc.

  • K904514 — STRUNG TELFA NON-ADHERENT SPONGE (March 27, 1991)
  • K902921 — RAYON NEUROLOGICAL SPONGE (September 18, 1990)
  • K872810 — STRUNG DENTAL ROLLS (December 4, 1987)
  • K872951 — AMERICAN BRAIN RETRACTOR COVER (September 16, 1987)
  • K872905 — AMERICAN NASAL SPONGE (September 4, 1987)
  • K872906 — SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE (August 11, 1987)
  • K872809 — GAUZE CHERRY SPONGE (August 4, 1987)
  • K872808 — CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 (August 4, 1987)
  • K872806 — STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG (August 4, 1987)
  • K872807 — NON-WOVEN TRACHEOTOMY SPONGE (August 4, 1987)

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)
  • 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)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911950 — MEDI GUARD DRAPES (May 21, 1991)

FDA data resources