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510(k) K823517

THE KLINE APPLICATOR by Kline Technologies, Ltd. — Product Code HGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1983
Date Received
November 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Vaginal
Device Class
Class I
Regulation Number
884.4520
Review Panel
OB
Submission Type