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510(k) K980212

MITYVAC by Prism Technologies, Inc. — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1998
Date Received
January 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractor, Vacuum, Fetal
Device Class
Class II
Regulation Number
884.4340
Review Panel
OB
Submission Type

Other clearances by Prism Technologies, Inc.

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  • K953541 — INSTANT COLDGEL (October 5, 1995)
  • K934631 — TRANSWARMER (February 3, 1994)
  • K912715 — INSTANT WARM GEL PACK (October 2, 1991)

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