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510(k) K812933

LANCER SPECIMEN CONTAINER by Sherwood Medical Co. — Product Code FMH

K812933 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "LANCER SPECIMEN CONTAINER". The FDA issued a decision of Substantially Equivalent on November 6, 1981. The device falls under product code FMH (Container, Specimen, Sterile), a Class I device regulated under 21 CFR 864.3250. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1981
Date Received
October 20, 1981
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 Sherwood Medical Co.

  • K981365 — MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (November 25, 1998)
  • K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. A (December 23, 1996)
  • K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (December 9, 1996)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K960677 — KANGAROO JEJUNAL FEEDING SYSTEM (May 13, 1996)
  • K960632 — KANGAROO FEEDING TUBE PLACMENT STYLET (May 9, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)
  • K954429 — KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT (March 8, 1996)
  • K954525 — SENSI-TOUCH EPIDURAL ANESTHESIA FILTER (January 19, 1996)
  • K950201 — ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (December 15, 1995)

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)
  • 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)
  • K792156 — LANCER SPECIMEN CONTAINER (December 10, 1979)

FDA data resources