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510(k) K844121

CLAMP, TUBING, LINE by Dyn-A-Med Products — Product Code FKK

K844121 is an FDA 510(k) premarket notification submitted by Dyn-A-Med Products for the device "CLAMP, TUBING, LINE". The FDA issued a decision of Substantially Equivalent on December 17, 1984. The device falls under product code FKK (Clamp, Line), a Class I device regulated under 21 CFR 876.4730. Dyn-A-Med Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1984
Date Received
October 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Line
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Dyn-A-Med Products

  • K813176 — GEL ELECTRODE (December 29, 1981)
  • K811157 — BLADE, TONGUE (May 27, 1981)
  • K802764 — PLASTIC ADHESIVE BANDAGE (November 24, 1980)
  • K802139 — SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY (October 31, 1980)

Other clearances for product code FKK

  • K854512 — TUBING CLAMP CAT#1000-A (December 2, 1985)
  • K854517 — NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (December 2, 1985)
  • K831689 — EMPTY DIALYSATE CONTAINER (August 11, 1983)
  • K822551 — AMP CAPD UNISPIKE AMINISTRATION SET (October 13, 1982)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)

FDA data resources