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510(k) K043526

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

K043526 is an FDA 510(k) premarket notification submitted by Noble Fiber Technologies, Inc. for the device "SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC". The FDA issued a decision of Substantially Equivalent on March 10, 2005. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Noble Fiber Technologies, Inc. has at least 7 other 510(k) clearances on record.

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

  • K973420 — CLINITEX CAST PADDING (December 9, 1997)
  • K973417 — CLINITEX STOCKINETTE (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)

FDA data resources