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510(k) K873957

NON-CORING HUBER TYPE NEEDLES by Advantage Medical Systems, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1987
Date Received
September 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Advantage Medical Systems, Inc.

  • K873290 — LACERATION AND INSTRUMENT TRAYS (September 24, 1987)
  • K863494 — NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (December 22, 1986)
  • K861556 — MODIFIED FETAL MONITOR MODEL FM-2 (July 7, 1986)
  • K861279 — FLUORO PLUS (June 16, 1986)
  • K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER (May 30, 1986)
  • K852518 — MODIFICATION FETAL MONITOR MODEL FM-2 (July 5, 1985)
  • K844724 — FETAL TELEMETRY SYSTEM (May 1, 1985)
  • K842462 — HOLTER SCREENING MONITOR HS-221 (September 11, 1984)
  • K840747 — TOCO DATA TELEPHONE TRANSMITTER DT100P (June 19, 1984)
  • K832849 — FETAL MONITOR #FM-2 (October 4, 1983)

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