510(k) K973942

SWIFT DELIVERY PRODUCT #300 by Swift Delivery Products — Product Code HDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1997
Date Received
September 26, 1997
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