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510(k) K780386

K-Y LUBRICATING JELLY by Johnson & Johnson Professionals, Inc. — Product Code FHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1978
Date Received
March 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Jelly, Lubricating, For Transurethral Surgical Instrument
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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Other clearances for product code FHX

  • K081990 — LUBRICANO STERILE GEL (December 5, 2008)
  • K951713 — BUTTON LUBRICATOR (April 25, 1995)
  • K935548 — CATHEJELL S STERILE LUBRICATING JELLY (March 30, 1994)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K771364 — LUBE JEL (August 2, 1977)