510(k) K132670

PANPAC INFLATABLE DOCUT PESSARY by Panpac Medical Corporation — Product Code HHW

K132670 is an FDA 510(k) premarket notification submitted by Panpac Medical Corporation for the device "PANPAC INFLATABLE DOCUT PESSARY". The FDA issued a decision of Substantially Equivalent on June 4, 2014. 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
June 4, 2014
Date Received
August 27, 2013
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