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510(k) K920677

CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION by New Dimensions IN Medicine, Inc. — Product Code NAE

K920677 is an FDA 510(k) premarket notification submitted by New Dimensions IN Medicine, Inc. for the device "CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION". The FDA issued a decision of Substantially Equivalent on Apr 21, 1992. 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. New Dimensions IN Medicine, Inc. has 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 21, 1992
Date Received
Feb 14, 1992
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
510(k) Exempt

Other clearances by New Dimensions IN Medicine, Inc.

  • K832145 — MONOBLOCK PROSTOPERATIVE TENS ELECTRODE (Jul 19, 1983)
  • K822077 — RESPIRATION MONITOR TYPE MR-10 (Oct 6, 1982)
  • K780631 — NDM INFANT ECG PACKPAD (May 3, 1978)
  • K780405 — INFANT ELECTROSURGICAL GROUNDING PAD (Apr 5, 1978)
  • K771749 — AMALGAM DISPENSER (Sep 28, 1977)

Other clearances for product code NAE

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

FDA data resources