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510(k) K870276

HEATED INSTRUMENT BATH by Simpson/Basye, Inc. — Product Code LRJ

K870276 is an FDA 510(k) premarket notification submitted by Simpson/Basye, Inc. for the device "HEATED INSTRUMENT BATH". The FDA issued a decision of Substantially Equivalent on May 7, 1987. The device falls under product code LRJ (Disinfectant, Medical Devices), a Class I device regulated under 21 CFR 880.6890. Simpson/Basye, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1987
Date Received
January 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disinfectant, Medical Devices
Device Class
Class I
Regulation Number
880.6890
Review Panel
HO
Submission Type

Other clearances by Simpson/Basye, Inc.

  • K926179 — SEDLACEK HANDLE (March 25, 1994)
  • K891352 — MARLOW ANAL SPECULUM (June 23, 1989)
  • K891351 — NEWPORT LATERAL VAGINAL RETRACTOR (May 11, 1989)
  • K891349 — CAMPION CERVICAL HOOK (March 29, 1989)
  • K891350 — NEWPORT CERVICAL MANIPULATOR (March 29, 1989)
  • K891347 — REID ENDOCERVICAL SPREADER (March 29, 1989)
  • K891348 — CAMPION LASER FORCEPS (March 22, 1989)
  • K862717 — HAND MIRROR (ENDOSCOPE) (July 30, 1986)
  • K862629 — SURGICAL LASER ACCESSORIES (SLA) CASE (July 17, 1986)
  • K790923 — MI-MARK ENDOCERVICAL SAMPLING SET (June 22, 1979)

Other clearances for product code LRJ

  • K992661 — CONTROL III ELITE (September 14, 1999)
  • K991509 — PRO-PORTION CLEANER/DISINFECTANT (July 14, 1999)
  • K984485 — MICROSTAT 2 (January 13, 1999)
  • K983947 — AMERSE 2 (December 4, 1998)
  • K983869 — DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH (November 30, 1998)
  • K983585 — LOW PH PHENOLIC 256 (November 6, 1998)
  • K982985 — CITREX HOSPITAL SPRAY DISINFECTANT (November 2, 1998)
  • K981023 — KLEENASEPTIC (April 30, 1998)
  • K980369 — T.B.Q. RTU (February 17, 1998)
  • K974304 — GERMICIDAL CLOTH (January 13, 1998)

FDA data resources