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510(k) K961444

GLOBAL MEDICAL COMBINED SPINAL EPIDURAL KIT (GMA 1827 AND GMA 1725) by Global Medical Products, Ltd. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1996
Date Received
April 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Global Medical Products, Ltd.

  • K970916 — H.V. PULSE LAVAGE (L31 SERIES) (June 20, 1997)
  • K962821 — EPIDURAL ANESTHESIA KIT AND COMBINED SPINAL EPIDURAL ANESTHESIA KIT (November 13, 1996)
  • K951448 — GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED S (March 27, 1996)
  • K951421 — GLOBAL MEDICAL PRODUCTS CHIBA, FRANSEEN, WESTCOTT STYLE, MENGHINI, TURNER, GREEN (November 16, 1995)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)

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