510(k) K092981

PANPAC VAGINAL PESSARY by Panpac Medical Corporation — Product Code HHW

K092981 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC VAGINAL PESSARY". The FDA issued a decision of Substantially Equivalent on July 22, 2010. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Panpac Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2010
Date Received
September 28, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type