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510(k) K884685

ROCKET FETAL BLOOD SAMPLING TRAY by A & A Medical, Inc. — Product Code HGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1989
Date Received
November 8, 1988
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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  • K994256 — SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823 (February 3, 2000)
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Other clearances for product code HGW

  • K891388 — 1570 - FETAL BLOOD SAMPLING KIT (March 28, 1989)
  • K831459 — FETAL BLOOD SAMPLING KIT #1560 (June 30, 1983)
  • K810028 — FETAL BLOOD SAMPLING KIT MODEL 1560 (January 16, 1981)