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510(k) K972646

AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES by Ludlow Technical Products — Product Code NAE

K972646 is an FDA 510(k) premarket notification submitted by Ludlow Technical Products for the device "AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES". The FDA issued a decision of Substantially Equivalent on August 21, 1997. 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. Ludlow Technical Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1997
Date Received
July 15, 1997
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 Ludlow Technical Products

  • K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUP (July 8, 1999)
  • K973110 — LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISP (October 21, 1997)
  • K964401 — KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) (February 6, 1997)
  • K931903 — SURELOCK(TM) SNAPLESS MONITORING ELECTRODE (October 7, 1993)

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)
  • 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)
  • K950412 — CURAGEL HYDROGEL WOUND DRESSING (March 24, 1995)

FDA data resources