510(k) K904026
K904026 is an FDA 510(k) premarket notification submitted by Milex Products, Inc. for the device "INFLAT-O-BALL". The FDA issued a decision of Substantially Equivalent on October 10, 1990. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Milex Products, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1990
- Date Received
- August 30, 1990
- 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