510(k) K931534
K931534 is an FDA 510(k) premarket notification submitted by Ovamed Corp. for the device "OVAMED INTRAUTERINE ACCESS CATHETER". The FDA issued a decision of Substantially Equivalent on July 28, 1995. The device falls under product code MOV (Catheters, Salpingography), a Class II device regulated under 21 CFR 884.4530. Ovamed Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1995
- Date Received
- March 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheters, Salpingography
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type