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510(k) K984564

ETHYL CHLORIDE DISPENSER by Dukal Corp. — Product Code MLY

K984564 is an FDA 510(k) premarket notification submitted by Dukal Corp. for the device "ETHYL CHLORIDE DISPENSER". The FDA issued a decision of Substantially Equivalent on December 2, 1999. The device falls under product code MLY (Vapocoolant Device), a Class U device. Dukal Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1999
Date Received
December 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vapocoolant Device
Device Class
Class U
Regulation Number
Review Panel
PM
Submission Type

Other clearances by Dukal Corp.

  • K252823 — Dukal Crepe Paper Sterilization Wrap (May 28, 2026)
  • K233262 — Dukal SMS Sterilization Wrap (March 22, 2024)
  • K083320 — DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE (March 6, 2009)
  • K070407 — DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE (March 26, 2007)
  • K061864 — DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, (September 15, 2006)
  • K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE (May 15, 2002)
  • K970457 — DUKAL ABD COMBINE PAD (May 8, 1997)
  • K970455 — DUKAL NON ADHERENT DRESSING (May 8, 1997)
  • K955476 — DUKAL TRANSPARENT WOUND DRESSING (January 18, 1996)
  • K940440 — DUKAL NON-WOVEN GAUZE (March 9, 1994)

Other clearances for product code MLY

  • K243654 — DentalJect (May 30, 2025)
  • K232674 — PainFreeze II (February 12, 2024)
  • K203661 — CRYO Arctic, CRYO Penguin (May 25, 2022)
  • K202782 — num Vapocoolant (December 21, 2020)
  • K201248 — Syringe Holder accessory (August 12, 2020)
  • K193349 — Vapocoolshot Mist (April 14, 2020)
  • K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chlo (May 7, 2019)
  • K172598 — Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic (April 19, 2018)
  • K172028 — Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium S (October 27, 2017)
  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)

FDA data resources