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510(k) K854902

SURGICOT STEAM TEST PACK by Surgicot, Inc. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1986
Date Received
December 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Surgicot, Inc.

  • K962605 — PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) (March 11, 1997)
  • K931270 — SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (April 13, 1994)
  • K863122 — ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. (December 17, 1986)
  • K855101 — ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR (July 17, 1986)
  • K854631 — ASSERT EO BIOLOGICAL TEST PACK (May 27, 1986)
  • K840541 — NEURO SPONGE (April 23, 1984)
  • K840471 — EYE SPEAR (March 16, 1984)
  • K840470 — SURGISCRIBE MARKING PEN (March 12, 1984)
  • K830739 — PRO-GUARD (March 29, 1983)
  • K820302 — SURGIPEEL SELF-SEAL PACKAGING SYSTEM (February 24, 1982)

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