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510(k) K800309

SPECIMEN COLLECTION PAN by Sage Products, Inc. — Product Code FMH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1980
Date Received
February 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Specimen, Sterile
Device Class
Class I
Regulation Number
864.3250
Review Panel
HO
Submission Type

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  • K970135 — NITRILE GLOVES (August 25, 1997)
  • K972302 — POCKET COUNT OR SAFETCOUNT (July 25, 1997)
  • K964168 — PROCEDURE SPECIFIC KITS (March 3, 1997)
  • K963986 — STP SYSTEM PVA WITH ZINC (November 8, 1996)
  • K964026 — STP SYSTEM - SAF (November 7, 1996)
  • K964027 — STP SYSTEM-PVA WITH MERCURY (November 1, 1996)

Other clearances for product code FMH

  • K900983 — TRI-TECH URINE SPECIMEN KIT (September 17, 1990)
  • K823763 — VARIOUS-SPECIMEN COLLECTORS (January 19, 1983)
  • K820180 — CALCULI FILTER CUP (February 5, 1982)
  • K812933 — LANCER SPECIMEN CONTAINER (November 6, 1981)
  • K802340 — SPECIMEN SET (October 10, 1980)
  • K802002 — URINE SPECIMEN CONTAINER #'S 1013-1016 (September 9, 1980)
  • K800947 — MIDSTREAM COLLECTION KIT (May 30, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)
  • K792156 — LANCER SPECIMEN CONTAINER (December 10, 1979)