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510(k) K950639

KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS by KARL STORZ Endoscopy-America, Inc. — Product Code MOK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1995
Date Received
February 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaginoscope And Accessories
Device Class
Class II
Regulation Number
884.1630
Review Panel
OB
Submission Type

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