510(k) K890565
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