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510(k) K920740

EPISENSOR PLUS by Industrias Palex C/O Dma Med-Chem Corp. — Product Code CAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
February 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Spinal-Fluid Pressure, Electrically Powered
Device Class
Class II
Regulation Number
880.2460
Review Panel
HO
Submission Type

Other clearances by Industrias Palex C/O Dma Med-Chem Corp.

  • K920368 — ULCUFLEX HYDROCOLLOID PASTE (March 26, 1992)
  • K920366 — ULCUFLEX HYDROCOLOID POWDER (March 26, 1992)
  • K920367 — ULCUFLEX HYDROCULLOID DRESSING (March 26, 1992)
  • K871628 — PALEX (R) OSTOMY (July 8, 1987)

Other clearances for product code CAR

  • K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM (June 15, 1993)
  • K915577 — IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE (March 11, 1992)