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510(k) K945832

BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS by Brady Medical Products Co. — Product Code NAE

K945832 is an FDA 510(k) premarket notification submitted by Brady Medical Products Co. for the device "BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic), a Class I device regulated under 21 CFR 878.4022. Brady Medical Products Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
November 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Device Class
Class I
Regulation Number
878.4022
Review Panel
SU
Submission Type

Other clearances by Brady Medical Products Co.

  • K941019 — BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING (May 4, 1994)
  • K936052 — BRADY MEDICAL PRODUCTS HYSORB(TM) WOUND DRESSING (March 7, 1994)
  • K935848 — BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING (February 15, 1994)
  • K922666 — TRANSORB(TM) ULCER & WOUND DRESSING (November 23, 1992)

Other clearances for product code NAE

  • K083721 — MODIFICATION TO ZENIEVA (January 8, 2009)
  • K082865 — MODIFICATION TO ZENIEVA (October 23, 2008)
  • K073246 — ZENIEVA (July 23, 2008)
  • K992094 — GILTECH PLUS HYDROGEL SKIN DRESSING (September 17, 1999)
  • K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (June 28, 1999)
  • K972646 — AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (August 21, 1997)
  • K971597 — COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (July 29, 1997)
  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K952945 — AQUAFLO HYDROGEL WOUND DRESSING & PACKER (August 23, 1995)
  • K951166 — BIODERM MEDICAL HYDROGEL ISLAND DRESSING (June 21, 1995)

FDA data resources