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510(k) K934601

NDM HYDROGAUZE WOUND DRESSING by Ndm Acquisition Corp. — Product Code NAE

K934601 is an FDA 510(k) premarket notification submitted by Ndm Acquisition Corp. for the device "NDM HYDROGAUZE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on February 15, 1994. 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. Ndm Acquisition Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1994
Date Received
September 24, 1993
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 Ndm Acquisition Corp.

  • K943287 — ACT-ONE ADVANCED COMPRESSION TECHNOLOGY FOOT PUMP (December 27, 1994)
  • K931457 — NDM SILVON ECG ELECTRODES (November 23, 1993)
  • K914207 — CLEARSITE(R) STERILE WOUND CARE DRESSING (October 23, 1991)

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