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510(k) K901459

DS60 TOOTHBRUSH SANITIZER by Associated Mills, Inc. — Product Code MCF

K901459 is an FDA 510(k) premarket notification submitted by Associated Mills, Inc. for the device "DS60 TOOTHBRUSH SANITIZER". The FDA issued a decision of Substantially Equivalent on September 17, 1990. The device falls under product code MCF (Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile), a Class I device regulated under 21 CFR 872.6855. Associated Mills, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1990
Date Received
March 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances by Associated Mills, Inc.

  • K872327 — WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 (September 4, 1987)
  • K871661 — WH150 ROOM HUMIDIFIER (June 15, 1987)
  • K862041 — WM10, WM20, WM30 POWER MASSAGER (June 17, 1986)
  • K862042 — SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (June 5, 1986)
  • K844397 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 (April 18, 1985)
  • K844396 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 (April 18, 1985)
  • K850362 — POLLENEX DIGITAL THERMOMETER T-125 (February 15, 1985)
  • K850363 — POLLENEX DIGITAL THERMOMETER T-225 (February 15, 1985)
  • K841095 — BP800, 850 1000 (August 24, 1984)
  • K841100 — HP-20, 30, 40, 50 & 60 (March 23, 1984)

Other clearances for product code MCF

  • K023662 — PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER (May 28, 2003)
  • K021258 — GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER (May 10, 2002)
  • K003517 — OTRES TOOTHBRUSH SANITIZER MODEL TB100W (June 6, 2001)
  • K896481 — PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER (May 15, 1990)

FDA data resources