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510(k) K910925

DISINFECTION WITH THE COX DRY HEAT STERILIZER by Cox Sterile Products, Inc. — Product Code KMH

K910925 is an FDA 510(k) premarket notification submitted by Cox Sterile Products, Inc. for the device "DISINFECTION WITH THE COX DRY HEAT STERILIZER". The FDA issued a decision of Substantially Equivalent on May 8, 1992. The device falls under product code KMH (Sterilizer, Dry Heat), a Class II device regulated under 21 CFR 880.6870. Cox Sterile Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1992
Date Received
March 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Dry Heat
Device Class
Class II
Regulation Number
880.6870
Review Panel
HO
Submission Type

Other clearances by Cox Sterile Products, Inc.

  • K922440 — STERIKING, SEE & PEEL (September 26, 1994)
  • K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (April 13, 1988)
  • K872643 — COX RAPID HEAT TRANSFER STERILIZER (October 29, 1987)

Other clearances for product code KMH

  • K094026 — STERI-DENT, STERI-SURE (July 12, 2011)
  • K051660 — DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM (August 4, 2005)
  • K910202 — DENTRONIX MODEL 2000 (March 13, 1991)
  • K880322 — DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM (July 13, 1988)
  • K881371 — COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE (April 13, 1988)
  • K872643 — COX RAPID HEAT TRANSFER STERILIZER (October 29, 1987)
  • K871615 — U. V. GERMICIDAL UNIT (September 11, 1987)
  • K851307 — INOX DRY HEAT STERILIZER (May 9, 1985)
  • K771070 — DRY HEAT STERILIZER (July 14, 1977)

FDA data resources