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510(k) K951703

TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS by Products For Medicine — Product Code LRT

K951703 is an FDA 510(k) premarket notification submitted by Products For Medicine for the device "TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code LRT (Indicator, Sterilization), a Class II device regulated under 21 CFR 880.2800. Products For Medicine has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
April 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Products For Medicine

  • K963227 — WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 (October 23, 1996)
  • K955510 — X6000D SILENT SUN LIGHT SOURCE (January 31, 1996)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K951704 — NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION (June 28, 1995)
  • K883658 — I-SPOSE EYE SHIELD (October 25, 1988)

Other clearances for product code LRT

  • K002937 — TST CONTROL INTEGRATOR FOR STEAM STERILIZERS (November 5, 2001)
  • K965154 — TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE (September 19, 1997)
  • K951113 — CROSS-CHECKS (August 19, 1996)
  • K871672 — STERILIZATION INDICATOR FOR FLASH STERILIZATION (June 1, 1987)

FDA data resources