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510(k) K791462

HYPERDERMIC NEEDLE WITH SENSOR #514 by Medtech Intl., Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
July 16, 1979
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 Medtech Intl., Inc.

  • K920876 — CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER (December 11, 1992)
  • K853843 — IV MATE (January 9, 1986)
  • K790467 — SURGICAL EYE SPONGE (March 26, 1979)
  • K790389 — GAUZE & COTTON SPONGES (March 26, 1979)
  • K781157 — STIMULATOR, NERVE, TRANSCUTANEOUS (September 20, 1978)

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