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510(k) K172028

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) by Gebauer Company — Product Code MLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2017
Date Received
July 5, 2017
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 Gebauer Company

  • K190161 — Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chlo (May 7, 2019)
  • K032671 — GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPR (March 17, 2004)
  • K031036 — GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN (July 10, 2003)
  • K021726 — GEBAUER'S INSTANT ICE (December 12, 2002)
  • K981693 — SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MO (August 6, 2001)
  • K002596 — GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 (February 15, 2001)
  • K001624 — GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 (January 25, 2001)
  • K991514 — GEBAUER'S CHLORIDE FINE NOZZE (July 16, 1999)
  • K930915 — FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE (September 29, 1994)

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  • K172598 — Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic (April 19, 2018)
  • K172203 — CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (October 18, 2017)
  • K162218 — Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model (November 22, 2016)