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510(k) K831459

FETAL BLOOD SAMPLING KIT #1560 by Transidyne General Corp. — Product Code HGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1983
Date Received
May 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sampler, Blood, Fetal
Device Class
Class II
Regulation Number
884.1560
Review Panel
OB
Submission Type

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Other clearances for product code HGW

  • K891388 — 1570 - FETAL BLOOD SAMPLING KIT (March 28, 1989)
  • K884685 — ROCKET FETAL BLOOD SAMPLING TRAY (January 12, 1989)
  • K810028 — FETAL BLOOD SAMPLING KIT MODEL 1560 (January 16, 1981)