510(k) K890565

GELLHORN PESSARY 33410 VARIOUS SIZES by Medi-Source, Inc. — Product Code HHW

K890565 is an FDA 510(k) premarket notification submitted by Medi-Source, Inc. for the device "GELLHORN PESSARY 33410 VARIOUS SIZES". The FDA issued a decision of Substantially Equivalent on March 29, 1989. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Medi-Source, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1989
Date Received
February 6, 1989
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