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510(k) K951140

KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR by Balagan Medical, Inc. — Product Code HFW

K951140 is an FDA 510(k) premarket notification submitted by Balagan Medical, Inc. for the device "KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR". The FDA issued a decision of Substantially Equivalent on May 25, 1995. The device falls under product code HFW (Clamp, Umbilical), a Class II device regulated under 21 CFR 884.4530.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1995
Date Received
March 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Umbilical
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances for product code HFW

  • K041332 — JOEY CLAMP OPENING TOOL (June 25, 2004)
  • K033846 — KAEN YIH UMBILICAL CORD CLAMP (March 11, 2004)
  • K020718 — SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE (June 3, 2002)
  • K021055 — BUSSE UMBILICAL CORD CLAMP CUTTER (April 29, 2002)
  • K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B (November 28, 2001)
  • K011621 — KOALA CLAMP, KOALA CLAMP AND CUTTER (August 10, 2001)
  • K010695 — KOALA CLAMP (May 3, 2001)
  • K010835 — POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLA (April 30, 2001)
  • K000227 — UMBICUT (April 27, 2000)
  • K994367 — UMBILICAL CORD CLAMP (March 17, 2000)

FDA data resources