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510(k) K954982

KSEA SCALP BLOOD COLLECTION SET by KARL STORZ Endoscopy-America, Inc. — Product Code HGK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1996
Date Received
October 31, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Fetal Blood Sampling (And Accessories)
Device Class
Class II
Regulation Number
884.1660
Review Panel
OB
Submission Type

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