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510(k) K781557

24-HOUR URINE COLLECTION COOLING WRAP by Sage Products, Inc. — Product Code FMH

K781557 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "24-HOUR URINE COLLECTION COOLING WRAP". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. Sage Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1978
Date Received
September 11, 1978
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

Other clearances by Sage Products, Inc.

  • K972705 — RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC (April 30, 1998)
  • K980490 — SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS (February 24, 1998)
  • K973911 — 2 GALLON ALTERNATE CARE SHARPS CONTAINER (October 29, 1997)
  • K972279 — SHARPS SHUTTLE (August 29, 1997)
  • 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)
  • K800309 — SPECIMEN COLLECTION PAN (February 26, 1980)
  • K800233 — ABCO MIDSTREAM URINE COLLECTION SET (February 26, 1980)
  • K792710 — PARA-PAK CLEAN VIAL (January 28, 1980)

FDA data resources