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510(k) K043526

SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC by Noble Fiber Technologies, Inc. — Product Code LGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2005
Date Received
December 21, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Cast
Device Class
Class I
Regulation Number
888.5940
Review Panel
OR
Submission Type

Other clearances by Noble Fiber Technologies, Inc.

  • K063190 — SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC (August 21, 2007)
  • K050726 — SILVERSEAL SILVERAID WITH X-STATIC (December 5, 2005)
  • K051256 — SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (July 21, 2005)
  • K050649 — SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC (June 13, 2005)
  • K033900 — X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING (January 14, 2005)
  • K033587 — SILVERSEAL (August 5, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)

Other clearances for product code LGF

  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K973420 — CLINITEX CAST PADDING (December 9, 1997)
  • K955320 — PROTEC COTTON PADDING BANDAGE (January 26, 1996)
  • K932507 — QUICK-CAST IMMOBILIZER (February 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (December 15, 1993)
  • K910274 — ARTIFLEX(TM) (March 5, 1991)
  • K903946 — COOL CAST(R) (December 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (June 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (August 30, 1988)
  • K874880 — COLORED CASTING TAPE CARAGLAS(TM GREEN (December 30, 1987)