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510(k) K961156

ONCE-A-DAY BOWIE AND DICK TEST PACK. by Propper Mfg. Co., Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1997
Date Received
March 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K991618 — BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR (January 24, 2001)
  • K991276 — PASS/FAIL CHALLENGE PACK (July 12, 1999)
  • K973585 — PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR (November 6, 1998)
  • K972747 — BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) (January 9, 1998)
  • K921798 — PROPPER SUPER SERACULT(R) (October 5, 1992)
  • K915804 — PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. (March 20, 1992)

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